FDA.reportPublic FDA data

Halyard

Primary DI
90680651513017
Brand
Halyard
Company
O&M HALYARD, INC.
Model
51301
Catalog number
51301
Device description
Prepping Pad
Published
2020-08-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LWGSURGICAL TABLE CUSHION

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LWGSurgical Table CushionGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30680651513015PrimaryGS10
90680651513017Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3068065151301530680651513015
9068065151301790680651513017

GMDN Terms#

Term, Definition table
TermDefinition
Patient surgical drape, single-use, non-sterileA non-sterile, noninvasive flat sheet designed to cover a portion of a patient’s anatomy during a surgical procedure to isolate a specific anatomical site (e.g., site of surgical incision) from potential contamination (e.g., microbial, substance). The device may also be used to protect a patient from heat/flame during a surgical procedure, however it is not designed with specific heat-reflective or laser resistant materials. This is a single-use device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(844)425-9273PIQ@hyh.com

Regulatory Flags#

DUNS number
081057389
Device count
50
DM exempt
false
Premarket exempt
true
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
30680651489532Halyard48953489532026-03-12
30680651497285Halyard49728497282026-03-04
30680651497292Halyard49729497292026-03-04
30680651497308Halyard49730497302026-03-04
30680651497315Halyard49731497312026-03-04
30680651497322Halyard49732497322026-03-04
30680651596810Halyard59681596812020-11-16
30680651596889Halyard59688596882020-11-16
30680651331015Halyard33101331012020-11-16
30680651331503Halyard33150331502020-11-16
30680651332012Halyard33201332012020-11-16
30680651334955Halyard33495334952020-11-16
30680651335006Halyard33500335002020-11-16
30680651337253Halyard33725337252020-11-16
90680651335107Halyard33510335102020-11-16
90680651337248Halyard33724337242020-11-16
30680651493645Halyard49364493642025-09-23
30680651493652Halyard49365493652025-09-23
30680651493409Halyard49340493402025-09-19
30680651493423Halyard49342493422025-09-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850055249431Prime Medical LLCPrime Medical LLCLWG2026-03-06
00850055249448Prime Medical LLCPrime Medical LLCLWG2026-03-06
00850055249455Prime Medical LLCPrime Medical LLCLWG2026-03-06
00850055249462Prime Medical LLCPrime Medical LLCLWG2026-03-06
00850055249479Prime Medical LLCPrime Medical LLCLWG2026-03-06
00850055249486Prime Medical LLCPrime Medical LLCLWG2026-03-06
00850055249493Prime Medical LLCPrime Medical LLCLWG2026-03-06
00850055249509Prime Medical LLCPrime Medical LLCLWG2026-03-06
00850055249516Prime Medical LLCPrime Medical LLCLWG2026-03-06
00850055249011Prime Medical LLCPrime Medical LLCLWG2026-03-05
00850055249028Prime Medical LLCPrime Medical LLCLWG2026-03-05
00850055249035Prime Medical LLCPrime Medical LLCLWG2026-03-05
00850055249042Prime Medical LLCPrime Medical LLCLWG2026-03-05
00850055249059Prime Medical LLCPrime Medical LLCLWG2026-03-05
00850055249103Prime Medical LLCPrime Medical LLCLWG2026-03-05
00850055249233Prime Medical LLCPrime Medical LLCLWG2026-03-05
00850055249240Prime Medical LLCPrime Medical LLCLWG2026-03-05
00850055249257Prime Medical LLCPrime Medical LLCLWG2026-03-05
00850055249264Prime Medical LLCPrime Medical LLCLWG2026-03-05
00850055249271Prime Medical LLCPrime Medical LLCLWG2026-03-05
00850055249288Prime Medical LLCPrime Medical LLCLWG2026-03-05
00850055249295Prime Medical LLCPrime Medical LLCLWG2026-03-05
00850055249301Prime Medical LLCPrime Medical LLCLWG2026-03-05
00850055249349Prime Medical LLCPrime Medical LLCLWG2026-03-05
00850055249356Prime Medical LLCPrime Medical LLCLWG2026-03-05
00850055249363Prime Medical LLCPrime Medical LLCLWG2026-03-05
00850055249370Prime Medical LLCPrime Medical LLCLWG2026-03-05
00850055249387Prime Medical LLCPrime Medical LLCLWG2026-03-05
00850055249394Prime Medical LLCPrime Medical LLCLWG2026-03-05
00850055249400Prime Medical LLCPrime Medical LLCLWG2026-03-05