FDA.reportPublic FDA data

Halyard

Primary DI
90680651513024
Brand
Halyard
Company
O&M HALYARD, INC.
Model
51302
Catalog number
51302
Device description
INSTRUSHIELD* Instrument Protection Device
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
30680651513022PrimaryGS10
90680651513024Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3068065151302230680651513022
9068065151302490680651513024

GMDN Terms#

Term, Definition table
TermDefinition
Surgical instrument containment holder, single-use, non-sterileA non-sterile device intended to be used in the operating room (OR) by staff to safely contain/support a delicate or sharp hand-held, manual, surgical instrument(s) [e.g., needle, scalpel, scissors] to avoid damage to the instrument during surgery and/or to enable easy transfer/handling of the instrument at reduced risk of injury. It is available in various forms (e.g., rack, rest, puncture cushion, pocket, magnetic mat), and may be attached to a surgical drape; it is not a numbered tray and is not intended for counting of sharps. 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
200
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
20680651509646Halyard50964509642026-05-14
20680651509653Halyard50965509652026-05-14
20680651509660Halyard50966509662026-05-14
20680651509677Halyard50967509672026-05-14
20680651509684Halyard50968509682026-05-14
20680651484219Halyard48421484212022-05-06
20680651484226Halyard48422484222022-05-06
10680651385250Halyard38525385252023-07-31
20680651372219Halyard37221372212020-11-16
20680651372509Halyard37250372502020-11-16
20680651718000Halyard71800718002020-08-31
20680651718253Halyard71825718252020-11-16
20680651719007Halyard71900719002020-11-16
30680651494390Halyard49439494392025-03-26
30680651494406Halyard49440494402025-03-26
30680651494413Halyard49441494412025-03-26
30680651494420Halyard49442494422025-03-26
30680651494437Halyard49443494432025-03-26
20680651395072Halyard39507395072020-09-15
20680651395089Halyard39508395082020-09-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10810087350946CoulmedCoulmed Products Group LLCLWG2023-01-12
10810087350953CoulmedCoulmed Products Group LLCLWG2023-01-12
10810087350960CoulmedCoulmed Products Group LLCLWG2023-01-12
10810087353343CoulmedCoulmed Products Group LLCLWG2023-01-12
10810087354005CoulmedCoulmed Products Group LLCLWG2023-01-12
10810087350908CoulmedCoulmed Products Group LLCLWG2023-01-06
10810087350915CoulmedCoulmed Products Group LLCLWG2023-01-06
10810087350922CoulmedCoulmed Products Group LLCLWG2023-01-06
10810087350939CoulmedCoulmed Products Group LLCLWG2023-01-06
10810087350977CoulmedCoulmed Products Group LLCLWG2023-01-06
10810087350984CoulmedCoulmed Products Group LLCLWG2023-01-06
10810087350991CoulmedCoulmed Products Group LLCLWG2023-01-06
10810087351004CoulmedCoulmed Products Group LLCLWG2023-01-06
10810087351028CoulmedCoulmed Products Group LLCLWG2023-01-06
10810087351035CoulmedCoulmed Products Group LLCLWG2023-01-06
10810087351042CoulmedCoulmed Products Group LLCLWG2023-01-06
10810087351059CoulmedCoulmed Products Group LLCLWG2023-01-06
10810087351066CoulmedCoulmed Products Group LLCLWG2023-01-06
10810087351080CoulmedCoulmed Products Group LLCLWG2023-01-06
10810087351097CoulmedCoulmed Products Group LLCLWG2023-01-06
10810087351387CoulmedCoulmed Products Group LLCLWG2023-01-06
10810087352001CoulmedCoulmed Products Group LLCLWG2023-01-06
10810087352162CoulmedCoulmed Products Group LLCLWG2023-01-06
10810087352179CoulmedCoulmed Products Group LLCLWG2023-01-06
10810087352186CoulmedCoulmed Products Group LLCLWG2023-01-06
10810087352193CoulmedCoulmed Products Group LLCLWG2023-01-06
10810087352209CoulmedCoulmed Products Group LLCLWG2023-01-06
10810087352216CoulmedCoulmed Products Group LLCLWG2023-01-06
10810087352223CoulmedCoulmed Products Group LLCLWG2023-01-06
10810087352230CoulmedCoulmed Products Group LLCLWG2023-01-06