FDA.reportPublic FDA data

McKesson

Primary DI
40612479258363
Brand
McKesson
Company
MCKESSON MEDICAL-SURGICAL INC.
Model
16-1862
Device description
AG Collagen Dressings 4x4" (10/bx, 10/cs)
Published
2020-06-25
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

Product Codes#

Code, Name table
CodeName
FRODressing, Wound, Drug

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FRODressing, Wound, DrugUnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K060804000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K060804000COLLAGRAN-COLLAGEN WOUND DRESSING, COLLAGRANAG-COLLAGEN W/SILVER ANTIMICROBIAL WOUND DRESSINGCovalon Technologies, Ltd.2006-04-18FRO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20612479258352PackageGS110In Commercial Distribution
40612479258363PackageGS110In Commercial Distribution
10612479258348PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2061247925835220612479258352
4061247925836340612479258363
1061247925834810612479258348

GMDN Terms#

Term, Definition table
TermDefinition
Collagen wound matrix dressingA sterile, bioabsorbable, animal-derived collagen protein matrix designed to provide an occlusive/semi-occlusive cover for wound healing (non-oral) and/or a skin template of living cells (fibroblasts) and/or structural proteins to facilitate the infiltration of native skin elements (e.g., fibroblasts, leukocytes, blood vessels) for skin regeneration. The device is used for various types of partial- and full-thickness wounds, draining wounds, sores/ulcers, skin lacerations/abrasions, burns, and/or surgical wounds. It may combine collagen with other compounds or supplemental dressing materials (e.g., alginate); it is supplied in various forms. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
023904428
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
true
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
00612479151291McKesson16-DEN-12026-07-09
00612479274648McKesson48392025-01-17
20612479285723McKessonGCCOV-502a-MB2026-06-18
20612479285747McKessonCCOVAg-PNMB2026-06-18
00612479271050McKesson16-L2NWT6Y-XL2024-04-17
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

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00852009002475Puracyn® Plus OTCInnovacyn, Inc.FRO2026-07-17
00852009002536Puracyn® Plus OTCInnovacyn, Inc.FRO2026-07-17
10197344169450MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-07-17
09551012610479ELECTROCYN somaV3BIO SDN. BHD.FRO2026-07-16
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00850088144604CARBOUNingbo kehu Medical Technology Co.,Ltd.FRO2026-07-10
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