FDA.reportPublic FDA data

AmerisourceBergen

Primary DI
00368001112062
Brand
AmerisourceBergen
Company
BP PHARMACEUTICALS LABORATORIES UNLIMITED COMPANY
Model
11206
Device description
"Laparotomy Sponges Non-sterile, Pre-washed 4"" X 18"""
Published
2021-05-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
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
60368001112064PackageGS120In Commercial Distribution
00368001112062PrimaryGS10
80368001112068Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
6036800111206460368001112064
00368001112062003680011120623680011120620368001112062
8036800111206880368001112068

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose surgical spongeA non-medicated cushion-like mass made of absorbent materials (e.g., woven gauze, 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 or cottonoid pad/pattie, it may also be used for prepping the patient. It does not contain special features to help detect gossypiboma (sponge left inside patient) [i.e., it is not radiopaque]. This is a single-use device.

Regulatory Flags#

DUNS number
985523874
Device count
5
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00368001112017AmerisourceBergen112012021-10-22
00368001112024AmerisourceBergen112022021-10-22
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
00368001103435AmerisourceBergen103432021-05-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956239692CARDINAL HEALTHCardinal Health 200, LLCGDY2025-11-28
07613327465853SurgiCount Safety-SpongeSTRYKER CORPORATIONGDY2025-09-03
10080196717811MEDLINEMEDLINE INDUSTRIES, INC.GDY2025-04-25
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
10326053119559Regard™Resource Optimization & Innovation, L.L.C.GDY2023-08-09
10326053119566Regard™Resource Optimization & Innovation, L.L.C.GDY2023-08-09
10326053119573Regard™Resource Optimization & Innovation, L.L.C.GDY2023-08-09
10326053119580Regard™Resource Optimization & Innovation, L.L.C.GDY2023-08-09
08600036785272USMEDCOUS MEDCO INCGDY2023-07-14
08600036785340USMEDCOUS MEDCO INCGDY2023-07-14
08600036785418USMEDCOUS MEDCO INCGDY2023-07-14
08600036785586USMEDCOUS MEDCO INCGDY2023-07-14
08600036785654USMEDCOUS MEDCO INCGDY2023-07-14
10197106046968CARDINAL HEALTHCardinal Health 200, LLCGDY2023-07-12
20192253050339CurityCardinal Health 200, LLCGDY2023-03-27
20192253050346CurityCardinal Health 200, LLCGDY2023-03-27
10192253050288KerlixCardinal Health 200, LLCGDY2023-03-24
10665973000012DukalDukal LLCGDY2022-12-06
10665973000029DukalDukal LLCGDY2022-12-06
10665973000036DukalDukal LLCGDY2022-12-06
10665973000050DukalDukal LLCGDY2022-12-06
10665973000067DukalDukal LLCGDY2022-12-06
10665973000081DukalDukal LLCGDY2022-12-06