FDA.reportPublic FDA data

Pakter

Primary DI
00827002122765
Brand
Pakter
Company
COOK INCORPORATED
Model
G12276
Catalog number
DCHNS-25-20.0-CURVE
Device description
Pakter Curved Needle Set
Published
2019-01-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
BSPNEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BSPNeedle, Conduction, Anesthetic (W/Wo Introducer)Anesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00827002122765PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00827002122765008270021227658270021227650827002122765

GMDN Terms#

Term, Definition table
TermDefinition
Spinal needle, single-useA sterile, sharp bevel-edged, hollow tubular metal instrument designed to deliver anaesthetic or analgesic agents intrathecally (in the space under the arachnoid membrane of the brain and spinal cord), withdraw a sample of cerebrospinal fluid (CSF), and/or assist introduction of an intrathecal catheter (e.g., lumboperitoneal shunt, spinal catheter). It is typically fenestrated, spring-tipped, and used for short-term administration; it is typically made of metal and plastic materials. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in dark, dry, cool place. Avoid extended exposure to light.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(812)330-5494sharedservices@cookmedical.com

Regulatory Flags#

DUNS number
042823948
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00827002613508SureTome SWG61350SUR-SW-352025-12-08
10827002613512SureTome SWG61351SUR-SW-AWG2-35-2602025-12-08
10827002613529SureTome SWG61352SUR-SW-AWG2-35-4502025-12-08
10827002242378BakriG24237J-SOSR-1005002016-09-24
10827002306735BakriG30673J-SOS-1005002016-09-24
00827002607842COOKG60784TESLA-B2535-2602025-07-22
00827002607859COOKG60785TESLA-B2535-4502025-07-22
10827002597508COOKG59750TESLA-B-ACU2025-07-11
10827002496535Cotton-Leung Sof-FlexG49653CLSO-SF-10-52015-11-03
00827002352674HerculesG35267HBDE-W-8-9-102022-12-20
00827002352681HerculesG35268HBDE-W-10-11-122022-12-20
00827002352698HerculesG35269HBDE-W-12-13.5-152022-12-20
00827002352704HerculesG35270HBDE-W-15-16.5-182022-12-20
00827002352711HerculesG35271HBDE-W-18-19-202022-12-20
10827002346014FusionG34601FS-OMNI-ACRO-35-2052016-09-24
10827002346939FusionG34693FS-OMNI-ACRO-35-2602016-09-24
10827002347110FusionG34711FS-OMNI-ACRO-35-4502016-09-24
10827002347783D.A.S.H.G34778DASH-ACRO-35-4502016-09-24
10827002347790D.A.S.H.G34779DASH-ACRO-25-4502016-09-24
10827002347806D.A.S.H.G34780DASH-ACRO-35-2602016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10818788022995Epimed International, Inc.EPIMED INTERNATIONAL, INCBSP2026-03-17
10193489242164MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.BSP2025-12-18
10193489631005MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.BSP2025-12-18
40888277832443MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.BSP2025-12-18
40888277832467MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.BSP2025-12-18
40888277832450MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.BSP2025-12-18
10193494001695PROBLOC* II Insulated Regional Block NeedleAvanos Medical, Inc.BSP2025-12-08
10193494001701PROBLOC* II Insulated Regional Block NeedleAvanos Medical, Inc.BSP2025-12-08
10193494001718PROBLOC* II Insulated Regional Block NeedleAvanos Medical, Inc.BSP2025-12-08
10193494001725PROBLOC* II Insulated Regional Block NeedleAvanos Medical, Inc.BSP2025-12-08
10193494001732PROBLOC* II Insulated Regional block NeedleAvanos Medical, Inc.BSP2025-11-28
10193494001749PROBLOC* II Insulated Regional block NeedleAvanos Medical, Inc.BSP2025-11-28
10193494001756PROBLOC* II Insulated Regional block NeedleAvanos Medical, Inc.BSP2025-11-28
10193494001763PROBLOC* II Insulated Regional block NeedleAvanos Medical, Inc.BSP2025-11-28
10193494001770ECHOBRIGHT* ECHOGENIC Single Shot Tuohy Needle with Stimulating CableAvanos Medical, Inc.BSP2025-11-28
10193494001787ECHOBRIGHT* ECHOGENIC Regional Block Needle with Injection SetAvanos Medical, Inc.BSP2025-11-28
10193494001794ECHOBRIGHT* ECHOGENIC Regional Block Needle with Injection SetAvanos Medical, Inc.BSP2025-11-28
10193494001800ECHOBRIGHT* ECHOGENIC Regional Block Needle with Injection SetAvanos Medical, Inc.BSP2025-11-28
10193494001817ECHOBRIGHT* ECHOGENIC Regional Block Needle with Injection SetAvanos Medical, Inc.BSP2025-11-28
10193494001824ECHOBRIGHT* ECHOGENIC Regional Block Needle with Injection SetAvanos Medical, Inc.BSP2025-11-28
10193494001831ECHOBRIGHT* ECHOGENIC Regional Block Needle with Injection SetAvanos Medical, Inc.BSP2025-11-28
10193494001848ECHOLONG* Continuous Nerve Block Set with Insulated ECHOGENIC NeedleAvanos Medical, Inc.BSP2025-11-28
10193494001855ECHOLONG* Continuous Nerve Block Set with Insulated ECHOGENIC NeedleAvanos Medical, Inc.BSP2025-11-28
10193494001862ECHOLONG* Continuous Nerve Block Set with Insulated ECHOGENIC NeedleAvanos Medical, Inc.BSP2025-11-28
10193494001879ECHOLONG* Continuous Nerve Block Set with Insulated ECHOGENIC NeedleAvanos Medical, Inc.BSP2025-11-28
10193494001886ECHOLONG* Continuous Nerve Block Set with Insulated ECHOGENIC NeedleAvanos Medical, Inc.BSP2025-11-28
10193494001893ECHOLONG* Continuous Nerve Block Set with Insulated ECHOGENIC NeedleAvanos Medical, Inc.BSP2025-11-28
10193494001909ECHOLONG* Continuous Nerve Block Set with Insulated ECHOGENIC NeedleAvanos Medical, Inc.BSP2025-11-28
10193494001916PROLONG* Continuous Nerve Block SetAvanos Medical, Inc.BSP2025-11-28
10193494001923PROLONG* Continuous Nerve Block SetAvanos Medical, Inc.BSP2025-11-28