FDA.reportPublic FDA data

Halyard

Primary DI
30680651143090
Brand
Halyard
Company
O&M HALYARD, INC.
Model
14309
Catalog number
1430903
Device description
HALYARD* SMART-FOLD* H650 Sterilization Wrap-121 x 154-48 X 61-H650-12-3-36
Published
2016-08-01
Public version status
Update
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
FRGWrap, sterilization

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FRGWrap, SterilizationGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30680651143090PackageGS13In Commercial Distribution
20680651143093PrimaryGS10
90680651143092Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3068065114309030680651143090
2068065114309320680651143093
9068065114309290680651143092

GMDN Terms#

Term, Definition table
TermDefinition
Sterilization packaging, single-useA device, typically in the form of a paper sheet, envelope, bag, wrap, or similar, intended to be used to contain medical devices that are to be sterilized. It is designed to allow sterilization of the enclosed medical device and also to maintain sterility of the device until the packaging is opened for use of the device, or until a predetermined shelf date is expired. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(844)425-9273xxx@xxx.xxx

Regulatory Flags#

DUNS number
081057389
Device count
12
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
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
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
00634916099225INSTRUMENT COVERSTANDARD TEXTILE CO., INC.FRG2026-03-11
10810132809986House Brand DentistryFrontier Dental Supply IncFRG2026-02-13
00810194400810AiraAIRA, LLCFRG2026-02-10
00810194400841AiraAIRA, LLCFRG2026-02-10
00810194400858AiraAIRA, LLCFRG2026-02-10
00810194400902AiraAIRA, LLCFRG2026-02-10
00810194400919AiraAIRA, LLCFRG2026-02-10
00810194400926AiraAIRA, LLCFRG2026-02-10
00810194400940AiraAIRA, LLCFRG2026-02-10
00810194400971AiraAIRA, LLCFRG2026-02-10
00810194400995AiraAIRA, LLCFRG2026-02-10
D8305514332MEDICOMAMD Medicom IncFRG2026-02-10
06438263667267Steriking®Wipak OyFRG2026-02-02
06438263667274Steriking®Wipak OyFRG2026-02-02
06438263667281Steriking®Wipak OyFRG2026-02-02
10197344148967MEDLINEMEDLINE INDUSTRIES, INC.FRG2026-01-23
10197344174454MEDLINEMEDLINE INDUSTRIES, INC.FRG2026-01-23
40080196752738MEDLINEMEDLINE INDUSTRIES, INC.FRG2026-01-22
40080196752745MEDLINEMEDLINE INDUSTRIES, INC.FRG2026-01-22
40080196752707MEDLINEMEDLINE INDUSTRIES, INC.FRG2026-01-21
00810194400896AiraAIRA, LLCFRG2026-01-16
00810194400933AiraAIRA, LLCFRG2026-01-16
00810194400964AiraAIRA, LLCFRG2026-01-16
06438263667250Steriking®Wipak OyFRG2025-12-30
06438263620378Steriking®Wipak OyFRG2025-12-30
06438263660640Steriking®Wipak OyFRG2025-12-30
06438263620392Steriking®Wipak OyFRG2025-12-30
06438263620408Steriking®Wipak OyFRG2025-12-30
06438263620415Steriking®Wipak OyFRG2025-12-30
06438263620422Steriking®Wipak OyFRG2025-12-30