FDA.reportPublic FDA data

McKesson

Primary DI
00612479141933
Brand
McKesson
Company
MCKESSON MEDICAL-SURGICAL INC.
Model
43-1-374
Device description
"Forceps, Bozeman Sponge Double-Curved 10.5"""
Published
2018-11-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
HDMPacker, Uterine

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HDMPacker, UterineObstetrics/Gynecology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00612479141933PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00612479141933006124791419336124791419330612479141933

GMDN Terms#

Term, Definition table
TermDefinition
Uterine packerA hand-held, surgical instrument used to introduce dressings into the uterus or vagina. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
023904428
Device count
1
Premarket exempt
true
Lot or batch
true
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
20612479282852McKessonM-1669H2026-05-26
20612479282883McKessonM-662G2026-05-26
20612479282890McKessonM-1667G2026-05-26
20612479282906McKessonM-1667H2026-05-26
20612479282913McKessonM-698G2026-05-26
20612479282920McKessonM-1666G2026-05-26
20612479282937McKessonM-1698G2026-05-26
20612479282944McKessonM-663G2026-05-26
20612479283019McKessonM-699G2026-05-26
20612479283194McKessonM-8699G2026-05-26
20612479283200McKessonM-8682G2026-05-26
20612479283217McKessonM-8698G2026-05-26
20612479283224McKessonM-8686G2026-05-26
20612479283231McKessonM-8697G2026-05-26
20612479283248McKessonM-8695G2026-05-26
20612479283255McKessonM-685G2026-05-26
20612479283385McKessonM-J494G2026-05-26
20612479283392McKessonM-J496G2026-05-26
20612479283408McKessonM-J493G2026-05-26
20612479283415McKessonM-J546G2026-05-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00612479143579McKessonMCKESSON MEDICAL-SURGICAL INC.HDM2020-05-04
00304040022993Henry ScheinHENRY SCHEIN, INC.HDM2019-05-16
10885403043437V. MuellerSTERIS CORPORATIONHDM2018-08-30
10885403043444V. MuellerSTERIS CORPORATIONHDM2018-08-30
10381780487043Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHDM2018-08-20
10381780487050Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHDM2018-08-20
10381780487067Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHDM2018-08-20
10381780487074Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHDM2018-08-20
H834308400Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHDM2018-08-20
H834308450Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHDM2018-08-20
H834308500Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHDM2018-08-20
H834308550Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHDM2018-08-20
10885403042126V. MuellerSTERIS CORPORATIONHDM2018-08-17
10381780409458Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHDM2018-08-16
10381780409465Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHDM2018-08-16
10381780409472Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHDM2018-08-16
10381780409489Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHDM2018-08-16
10381780409496Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHDM2018-08-16
10381780479468Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHDM2018-08-16
M274X419461Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHDM2018-08-16
M274X419511Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHDM2018-08-16
M274X419561Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHDM2018-08-16
M274X419611Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHDM2018-08-16
M274X419661Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHDM2018-08-16
H834308350Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHDM2018-08-16
10381780438441Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHDM2018-01-24
10381780440734Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHDM2018-01-24
H834MH76220Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHDM2018-01-24
10381780416548Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHDM2017-10-30
H834V976220Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHDM2017-10-30