FDA.reportPublic FDA data

Epimed

Primary DI
00818788020567
Brand
Epimed
Company
EPIMED INTERNATIONAL, INC
Model
116-2245
Catalog number
116-2245
Device description
"22g RW x 4.5"" Blunt Nerve Block Needle"
Published
2017-10-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K041843000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K041843000PENCIL POINT NEEDLEEpimed International, Inc.2004-08-24BSP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10818788020564PackageGS110In Commercial Distribution
00818788020567PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081878802056410818788020564
00818788020567008187880205678187880205670818788020567

GMDN Terms#

Term, Definition table
TermDefinition
Peripheral nerve-block blunt needleA sterile slender hand-held metal tube with a dull, straight or bent (coude) tip designed to atraumatically access a peripheral nerve for the injection of an anaesthetic/analgesic agent for nerve-block/pain control (e.g., sleeve blocks, deep muscle blocks, hypogastric blocks, paravertebral blocks, joint blocks, selective nerve root, lumbar sympathetic, Coeliac plexus). It may be used to deliver anaesthetic or analgesic agents directly and/or to allow introduction of a dedicated catheter for administration. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0
Length4.5Inch
Needle Gauge22Gauge

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature50 Degrees Fahrenheit90 Degrees Fahrenheit

Sterilization Methods#

Method table
Method
Ethylene Oxide

Contacts#

Phone, Email table
PhoneEmail
+1(800)866-3342customerservice@epimed.com

Regulatory Flags#

DUNS number
799751953
Device count
1
DM exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00818788022998Epimed International, Inc.104-13142026-03-17
10818788022995Epimed International, Inc.104-13142026-03-17
00818788022295Epimed International, Inc.401-PBSYS2025-12-05
00818788021892Epimed International, Inc.325-4LRFG325-4LRFG2025-11-21
00818788022943Epimed International, Inc258-2205258-22052025-11-21
00818788022950Epimed International, Inc259-2010259-20102025-11-21
00818788022967Epimed International, Inc284-2010284-20102025-11-21
00818788022981Epimed291-C04291-C042017-10-24
00818788023650Epimed282-16102024-06-04
00818788023667Epimed282-16152024-06-04
00818788023681Epimed107-1618107-16182023-11-21
00818788021472Epimed189-2340189-23402017-10-24
00818788021564Epimed270-2015270-20152017-10-24
00818788021922Epimed265-2010265-20102017-10-24
00818788021939Epimed265-2015265-20152017-10-24
00818788021977Epimed268-2010268-20102017-10-24
00818788022066Epimed268-2015268-20152017-10-24
00818788022097Epimed270-2010270-20102017-10-24
00818788023599Epimed125-1820T125-1820T2021-06-17
00818788021281Epimed170-2124170-21242017-10-24

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Primary DI, Brand, Company table
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M661S103418500Plastic BD Style Hub Tuohy Epidural NeedleSpectra Medical Devices, LLCBSP2024-06-18
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M661S80C22200MSK Ultrasonic Injection NeedleSpectra Medical Devices, LLCBSP2024-06-18
M661S80C23200MSK Ultrasonic Injection NeedleSpectra Medical Devices, LLCBSP2024-06-18
M661S90C22600MSK Ultrasonic Injection NeedleSpectra Medical Devices, LLCBSP2024-06-18
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M661S80C21200MSK Ultrasonic Injection NeedleSpectra Medical Devices, LLCBSP2024-02-12
M661S80C21400MSK Ultrasonic Injection NeedleSpectra Medical Devices, LLCBSP2024-02-12
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10612479261065McKessonMCKESSON MEDICAL-SURGICAL INC.BSP2022-07-19
10612479261096McKessonMCKESSON MEDICAL-SURGICAL INC.BSP2022-07-19
10612479261126McKessonMCKESSON MEDICAL-SURGICAL INC.BSP2022-07-19
10612479261157McKessonMCKESSON MEDICAL-SURGICAL INC.BSP2022-07-19
10193489253023Medline Industries, Inc.MEDLINE INDUSTRIES, INC.BSP2021-08-27
10193489550115MedlineMEDLINE INDUSTRIES, INC.BSP2021-01-28
10193489270990MedlineMEDLINE INDUSTRIES, INC.BSP2021-01-27
10680651479096HalyardAvanos Medical, Inc.BSP2019-07-15
10680651477566HalyardAvanos Medical, Inc.BSP2019-06-15