FDA.reportPublic FDA data

AmerisourceBergen

Primary DI
60368001112095
Brand
AmerisourceBergen
Company
BP PHARMACEUTICALS LABORATORIES UNLIMITED COMPANY
Model
11209
Device description
Laparotomy Sponges X-Ray Detectable Pre-washed Sterile
Published
2021-05-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
GDYGauze/Sponge, Internal, X-Ray Detectable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GDYGauze/Sponge, Internal, X-Ray DetectableGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
60368001112095PackageGS120In Commercial Distribution
00368001112093PrimaryGS10
80368001112099Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
6036800111209560368001112095
00368001112093003680011120933680011120930368001112093
8036800111209980368001112099

GMDN Terms#

Term, Definition table
TermDefinition
Radiopaque woven surgical sponge, sterileA non-medicated sterile device made from woven gauze (e.g., cotton, cellulose) primarily intended to be used inside the body, on a surgical incision or applied to internal organs or structures to control bleeding, absorb fluid, or protect organs or structures from abrasion, drying, or contamination during a procedure; also referred to as a laparotomy sponge, it may also be used for prepping the patient. It contains an x-ray detectable marker [e.g., a thread or strand(s)] to help detect gossypiboma (sponge left inside patient). This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
985523874
Device count
5
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
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
00368001112017AmerisourceBergen112012021-10-22
00368001112024AmerisourceBergen112022021-10-22
00368001112062AmerisourceBergen112062021-05-17
00368001112079AmerisourceBergen112072021-05-17
00368001112086AmerisourceBergen112082021-05-18
00368001112093AmerisourceBergen112092021-05-18
00368001112109AmerisourceBergen112102021-05-18
00368001105385AmerisourceBergen105382018-10-26
00368001105408AmerisourceBergen105402018-10-26
00368001105415AmerisourceBergen105412018-10-26
00368001105422AmerisourceBergen105422018-10-26
00368001105392AmerisourceBergen105392018-10-26
00368001103275AmerisourceBergen103272021-10-20
00368001103282AmerisourceBergen103282021-10-20
00368001103299AmerisourceBergen103292021-10-20
00368001103305AmerisourceBergen103302021-10-20
00368001103312AmerisourceBergen103312021-10-20
00368001103329AmerisourceBergen103322021-10-20
00368001103367AmerisourceBergen103362021-11-01
00368001103374AmerisourceBergen103372021-11-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00199536924000BluelineTransparent Supply Solutions Ltd.GDY2026-08-07
00199536924024BluelineTransparent Supply Solutions Ltd.GDY2026-08-07
00199536924031BluelineTransparent Supply Solutions Ltd.GDY2026-08-07
00199536924055BluelineTransparent Supply Solutions Ltd.GDY2026-08-07
10198956239692CARDINAL HEALTHCardinal Health 200, LLCGDY2025-11-28
00850049994866SynterventionZien Medical Technologies, LLCGDY2025-09-26
00850049994873SynterventionZien Medical Technologies, LLCGDY2025-09-26
00850049994880SynterventionZien Medical Technologies, LLCGDY2025-09-26
00850049994897SynterventionZien Medical Technologies, LLCGDY2025-09-26
00850049994903SynterventionZien Medical Technologies, LLCGDY2025-09-26
00850049994910SynterventionZien Medical Technologies, LLCGDY2025-09-26
00850049994927SynterventionZien Medical Technologies, LLCGDY2025-09-26
00850049994934SynterventionZien Medical Technologies, LLCGDY2025-09-26
00850049994941SynterventionZien Medical Technologies, LLCGDY2025-09-26
00850049994958SynterventionZien Medical Technologies, LLCGDY2025-09-26
00850049994965SynterventionZien Medical Technologies, LLCGDY2025-09-26
00850049994972SynterventionZien Medical Technologies, LLCGDY2025-09-26
00850049994996SynterventionZien Medical Technologies, LLCGDY2025-09-23
00850049994989SynterventionZien Medical Technologies, LLCGDY2025-09-22
07613327465853SurgiCount Safety-SpongeSTRYKER CORPORATIONGDY2025-09-03
10080196717811MEDLINEMEDLINE INDUSTRIES, INC.GDY2025-04-25
10810178830005Tally Surgical SolutionTally Surgical, Inc.GDY2025-02-18
10197106760994CARDINAL HEALTHCardinal Health 200, LLCGDY2025-01-29
10080196031313MEDLINEMEDLINE INDUSTRIES, INC.GDY2025-01-16
10080196743926MEDLINEMEDLINE INDUSTRIES, INC.GDY2024-10-15
10326053119504Regard™Resource Optimization & Innovation, L.L.C.GDY2023-08-09
10326053119511Regard™Resource Optimization & Innovation, L.L.C.GDY2023-08-09
10326053119528Regard™Resource Optimization & Innovation, L.L.C.GDY2023-08-09
10326053119535Regard™Resource Optimization & Innovation, L.L.C.GDY2023-08-09
10326053119542Regard™Resource Optimization & Innovation, L.L.C.GDY2023-08-09