FDA.report

Halyard

Primary DI
30680651105029
Brand
Halyard
Company
O&M HALYARD, INC.
Model
10502
Catalog number
10502
Device description
ABSORBENT TRAY LINER, 20 IN. X 25 IN. / 51 CM X 64 CM.
Published
2016-04-21
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
KKXDrape, surgical

Product Code Classifications

CodeDeviceSpecialtyClass
KKXDrape, SurgicalGeneral, Plastic Surgery2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
30680651105029PackageGS18Not in Commercial Distribution
20680651105022PrimaryGS10
90680651105021Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
3068065110502930680651105029
2068065110502220680651105022
9068065110502190680651105021

GMDN Terms

TermDefinition
General/plastic surgical procedure kit, non-medicated, single-useA collection of various sterile surgical instruments, sometimes with dressings and/or other materials, intended to be used to: 1) assist a range of surgical procedures across multiple clinical specialities typically as a general-purpose tray; or 2) assist with a plastic surgery procedure. It does not contain pharmaceuticals. This is a single-use device.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(844)425-9273xxx@xxx.xxx

Regulatory Flags

DUNS number
081057389
Device count
50
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
false
Sterilization required before use
false

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30680651335006Halyard33500335002020-11-16
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30680651493423Halyard49342493422025-09-19

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26975424198832Exact Medical Manufacturing, Inc.EXACT MEDICAL MANUFACTURING, INC.KKX2026-03-09
16975424199276Exact Medical Manufacturing, Inc.EXACT MEDICAL MANUFACTURING, INC.KKX2026-03-09
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