NA

Primary DI
03700393300639
Brand
NA
Company
PETERS SURGICAL
Model
AIG2150
Catalog number
AIG2150
Device description
Single use, pneumoperitoneum needle for laparoscopic surgery
Published
2016-09-12
Public version status
Update
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
FHPNeedle, Pneumoperitoneum, Simple

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FHPNeedle, Pneumoperitoneum, SimpleGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K121370000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K121370000VECTEC DISPOSABLE PNEUMOPERITONEUM NEEDLEVectec2013-08-02FHO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03700393300639PackageGS125In Commercial Distribution
03700393300646PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03700393300639037003933006393700393300639
03700393300646037003933006463700393300646

GMDN Terms#

Term, Definition table
TermDefinition
Spring-loaded pneumoperitoneum needle, single-useA slender, sharply-pointed metal tube designed to introduce or remove gas from the peritoneal cavity as a therapeutic or surgical/radiological procedural method. It is often inserted into the peritoneal cavity for the purpose of insufflation [e.g., with carbon dioxide (CO2)] to establish pneumoperitoneum prior to abdominal endoscopy. It is equipped with a spring-loaded, round-tipped obturator that extends from the tube when the device does not encounter resistance (i.e., when the cavity has been reached) to prevent damage from the sharp point. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+33470584170vectec@vectec.fr
+1 508-747-6033e.knupp@peters-surgical.com

Regulatory Flags#

DUNS number
265741780
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
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03661522011782CARDIOXYL ®73S15B2020-01-04
03661522011805CARDIOXYL ®73P30A2020-01-04
03661522011812CARDIOXYL ®73P30B2020-01-04
03661522011829CARDIOXYL ®73P30D2020-01-04
03661522011836CARDIOXYL ®73P30E2020-01-04
03661522011843CARDIOXYL ®73P30F2020-01-04
03661522011850CARDIOXYL ®73P30G2020-01-04
03661522011867CARDIOXYL ®73P30I2020-01-04
03661522011874CARDIOXYL ®73P30J2020-01-04
03661522011881CARDIOXYL ®73P30K2020-01-04
03661522011898CARDIOXYL ®73P30L2020-01-04
03661522011904CARDIOXYL ®73P30O2020-01-04
03661522011911CARDIOXYL ®73P30P2020-01-04
03661522011928CARDIOXYL ®73P30Q2020-01-04
03661522011935CARDIOXYL ®73P30R2020-01-04
03661522011942CARDIOXYL ®73P30S2020-01-04
03661522011959CARDIOXYL ®73P30T2020-01-04
03661522011966CARDIOXYL ®73S15C2020-01-04
03661522011973CARDIOXYL ®73S20A2020-01-04
03661522011980CARDIOXYL ®73S20B2020-01-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03700393300622NAPETERS SURGICALFHP2016-09-12
03700393300646NAPETERS SURGICALFHP2016-09-12
03700393300615NAPETERS SURGICALFHP2016-09-12