FDA.reportPublic FDA data

McKesson

Primary DI
40612479123937
Brand
McKesson
Company
MCKESSON MEDICAL-SURGICAL INC.
Model
16-3M-1248
Device description
Stockinette STERILE |IMPERVIOUS |TUBULAR POLYESTER | SINGLE PLY 12 in. x 48 in.
Published
2018-09-12
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
LROGeneral Surgery Tray
PUIDrape, Surgical, Exempt

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LROGeneral Surgery TrayGeneral, Plastic Surgery2
PUIDrape, Surgical, ExemptGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K893814000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K893814000SURGICAL INSTRUMENT KIT, DISPOSABLEBioseal1989-08-10LRO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
40612479123937PackageGS110In Commercial Distribution
20612479123667PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
4061247912393740612479123937
2061247912366720612479123667

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
false
Expiration date on label
false
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
20612479288496McKesson16-SN1C2905ST2026-10-08
20612479288526McKesson16-SN05C2905ST2026-10-08
20612479288557McKesson16-SN1C2805ST2026-10-08
20612479288588McKesson16-SN1C2558ST2026-10-08
10612479285993McKessonEXT-STND-070-0652026-10-06
10612479286013McKessonEXT-SM-030-0802026-10-06
10612479235592McKesson16-18502020-06-10
10612479235608McKesson16-18522020-06-10
10612479258317McKesson16-18602020-06-25
10612479258348McKesson16-18622020-06-25
20612479203710McKesson326302020-07-21
10612479169064McKesson101-87032016-12-09
10612479169125McKesson101-87102016-12-09
10612479284002McKesson16-6219-B2026-08-03
10612479284026McKesson16-6218-B2026-08-03
10612479284040McKesson16-6220-B2026-08-03
10612479284064McKesson16-6221-B2026-08-03
10612479284101McKesson16-6379-B2026-08-03
10612479284125McKesson16-6216-B2026-08-03
00612479151291McKesson16-DEN-12026-07-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10198956499294CARDINAL HEALTHCardinal Health 200, LLCLRO2026-11-05
10198956503267CARDINAL HEALTHCardinal Health 200, LLCLRO2026-11-05
10198956506503CARDINAL HEALTHCardinal Health 200, LLCLRO2026-11-05
10198956509566CARDINAL HEALTHCardinal Health 200, LLCLRO2026-11-05
10198956539792CARDINAL HEALTHCardinal Health 200, LLCLRO2026-11-05
10198956554412CARDINAL HEALTHCardinal Health 200, LLCLRO2026-11-05
10198956555808CARDINAL HEALTHCardinal Health 200, LLCLRO2026-11-05
10198956567719CARDINAL HEALTHCardinal Health 200, LLCLRO2026-11-05
10198956568020CARDINAL HEALTHCardinal Health 200, LLCLRO2026-11-05
10198956568297CARDINAL HEALTHCardinal Health 200, LLCLRO2026-11-05
10198956569935CARDINAL HEALTHCardinal Health 200, LLCLRO2026-11-05
10198956573802CARDINAL HEALTHCardinal Health 200, LLCLRO2026-11-05
10198956578173CARDINAL HEALTHCardinal Health 200, LLCLRO2026-11-05
10198956581166CARDINAL HEALTHCardinal Health 200, LLCLRO2026-11-05
10198956581180CARDINAL HEALTHCardinal Health 200, LLCLRO2026-11-05
10198956584143CARDINAL HEALTHCardinal Health 200, LLCLRO2026-11-05
10198956585355CARDINAL HEALTHCardinal Health 200, LLCLRO2026-11-05
10198956586420CARDINAL HEALTHCardinal Health 200, LLCLRO2026-11-05
10198956586789CARDINAL HEALTHCardinal Health 200, LLCLRO2026-11-05
10198956588325CARDINAL HEALTHCardinal Health 200, LLCLRO2026-11-05
10198956588417CARDINAL HEALTHCardinal Health 200, LLCLRO2026-11-05
10198956590762CARDINAL HEALTHCardinal Health 200, LLCLRO2026-11-05
10198956590854CARDINAL HEALTHCardinal Health 200, LLCLRO2026-11-05
10198956591059CARDINAL HEALTHCardinal Health 200, LLCLRO2026-11-05
10198956591073CARDINAL HEALTHCardinal Health 200, LLCLRO2026-11-05
10198956591158CARDINAL HEALTHCardinal Health 200, LLCLRO2026-11-05