FDA.reportPublic FDA data

Halyard

Primary DI
10885632351211
Brand
Halyard
Company
OWENS & MINOR DISTRIBUTION, INC.
Model
DP0400
Device description
Punch Biopsy Dermal Stainless Steel Polystyrene 4 Millimeter Sterile Not Made With Natural Rubber Latex Halyard
Published
2022-03-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
LRYPUNCH, SURGICAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LRYPunch, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20885632351218PackageGS125In Commercial Distribution
10885632351211PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088563235121820885632351218
1088563235121110885632351211

GMDN Terms#

Term, Definition table
TermDefinition
Open-surgery biopsy forceps, single-useA hand-held manual surgical instrument designed to obtain soft-tissue biopsy specimens from an open surgical wound or from within/near a large natural orifice (e.g., vagina, rectum) for histopathological examination; it is not intended for endoscopic or catheterized access. It is a metallic forceps-like instrument with a distal mechanism designed to bite/punch the biopsy sample and hold it for extraction when the handles are squeezed together. It is not designed for cutting bone (i.e., not a rongeur). This is a single-use device.

Regulatory Flags#

DUNS number
007941230
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10885632529412SurgiTrackSM450070BF4D2026-08-07
10885632529429SurgiTrackSM450070519D2026-08-07
10885632529436SurgiTrackSM450070758A2026-08-07
10885632528620SurgiTrackSM450165D15C2026-08-03
10885632528286SurgiTrackSM450041FF302026-07-31
10885632527500SurgiTrackSM4501879FD72026-07-20
10885632527517SurgiTrackSM450087479A2026-07-20
10885632527524SurgiTrackSM45008787D62026-07-20
10885632527531SurgiTrackSM4500876D452026-07-20
10885632527548SurgiTrackSM4500455A9F2026-07-20
10885632524950SurgiTrackSM450087F0132026-07-10
10885632526978SurgiTrackSM450087C13B2026-07-10
10885632526992SurgiTrackSM4500415EEA2026-07-10
10885632524936SurgiTrackSM450087A18C2026-07-09
10885632524943SurgiTrackSM4500872B162026-07-09
10885632524882SurgiTrackSM4500877C312026-07-08
10885632524899SurgiTrackSM45008780392026-07-08
10885632524905SurgiTrackSM45008766152026-07-08
10885632524912SurgiTrackSM45008762622026-07-08
10885632524929SurgiTrackSM450087F5C22026-07-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B382SD441309197120Surgical DirectSurgical Direct, Inc.LRY2026-08-03
03701089526586AMPLITUDEAMPLITUDE SASLRY2026-07-29
03701089527187AMPLITUDEAMPLITUDE SASLRY2026-07-29
03701089527194AMPLITUDEAMPLITUDE SASLRY2026-07-29
B382SD323690Surgical DirectSurgical Direct, Inc.LRY2026-07-28
B382SD323790Surgical DirectSurgical Direct, Inc.LRY2026-07-28
B8035903160ORTHOMEDORTHO-MED, INC.LRY2026-07-22
B8034800100ORTHOMEDORTHO-MED, INC.LRY2026-07-14
04946329039580Kerrison Rongeur 150 x 2 mm, 35 deg, UpwardMIZUHO CORPORATIONLRY2026-06-03
04946329039597Kerrison Rongeur 150 x 3 mm, 35 deg, UpwardMIZUHO CORPORATIONLRY2026-06-03
04946329039603Kerrison Rongeur 150 x 4 mm, 35 deg, UpwardMIZUHO CORPORATIONLRY2026-06-03
04946329039610Kerrison Rongeur 150 x 5 mm, 35 deg, UpwardMIZUHO CORPORATIONLRY2026-06-03
04946329039627Kerrison Rongeur 180 x 3 mm, 35 deg, UpwardMIZUHO CORPORATIONLRY2026-06-03
04946329039634Kerrison Rongeur 180 x 4 mm, 35 deg, UpwardMIZUHO CORPORATIONLRY2026-06-03
04946329039641Kerrison Rongeur 180 x 5 mm, 35 deg, UpwardMIZUHO CORPORATIONLRY2026-06-03
04946329039658Kerrison Rongeur 180 x 1 mm, 35 deg, UpwardMIZUHO CORPORATIONLRY2026-06-03
00846338005801KerrisonELLIQUENCE, LLCLRY2026-06-02
00846338005818KerrisonELLIQUENCE, LLCLRY2026-06-02
00846338005825KerrisonELLIQUENCE, LLCLRY2026-06-02
00846338005832KerrisonELLIQUENCE, LLCLRY2026-06-02
00846338005849KerrisonELLIQUENCE, LLCLRY2026-06-02
00846338005856KerrisonELLIQUENCE, LLCLRY2026-06-02
00846338005870KerrisonELLIQUENCE, LLCLRY2026-06-02
00846338005887KerrisonELLIQUENCE, LLCLRY2026-06-02
00846338005894KerrisonELLIQUENCE, LLCLRY2026-06-02
00846338005900KerrisonELLIQUENCE, LLCLRY2026-06-02
00846338005924KerrisonELLIQUENCE, LLCLRY2026-06-02
00846338005931KerrisonELLIQUENCE, LLCLRY2026-06-02
00846338005948KerrisonELLIQUENCE, LLCLRY2026-06-02
00846338005955KerrisonELLIQUENCE, LLCLRY2026-06-02