FDA.reportPublic FDA data

Brasseler USA

Primary DI
00887919594321
Brand
Brasseler USA
Company
Peter Brasseler Holdings, LLC
Model
5015036U0
Device description
47.959.01 BONE SCRAPER 1P
Published
2022-12-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
00887919594321PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00887919594321008879195943218879195943210887919594321

GMDN Terms#

Term, Definition table
TermDefinition
Skin-coring punch, reusableA hand-held manual surgical instrument designed to cut out (core) sections of skin as part of a dermatological procedure to remove skin lesions or to obtain skin-tissue specimens. It consists of a handle and a cylindrical distal tip which has a bevelled, sharp cutting edge, which when pressed into the skin surface and gently rotated will penetrate and cut through the skin allowing that section to be removed. It is typically metallic and is available in various cutting head sizes; it is not a biopsy gun. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
082080136
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00887919956815LARGE BONE BLADESSAW6944TSAW6944T2026-10-27
00887919956846LARGE BONE BLADESSAW6945TSAW6945T2026-10-27
00887919956877LARGE BONE BLADESSAW6946TSAW6946T2026-10-27
00887919956969LARGE BONE BLADESSAW6949TSAW6949T2026-10-27
00887919956990LARGE BONE BLADESSAW6950TSAW6950T2026-10-27
00887919957027LARGE BONE BLADESSAW6951TSAW6951T2026-10-27
00887919956907LARGE BONE BLADESSAW6947TSAW6947T2026-10-26
00887919956938LARGE BONE BLADESSAW6948TSAW6948T2026-10-26
08404535025309Brasseler USA5032037U05032037U02026-04-29
00887919673880Brasseler USA5022563U05022563U02023-01-25
00887919676218Brasseler USA5022790U05022790U02023-01-25
00887919676232Brasseler USA5022792U05022792U02023-01-25
00887919676249Brasseler USA5022793U05022793U02023-01-25
00887919810926Brasseler USA5026807U05026807U02023-01-25
08404535020779Brasseler USA5031841U05031841U02026-10-20
08404535020809Brasseler USA5031842U05031842U02026-10-20
08404535037654Brasseler USA5032402U05032402U02026-10-20
08404535037685Brasseler USA5032403U05032403U02026-10-20
08404535036985Brasseler USA5032405U05032405U02026-10-01
00887919581703DENTFLEX FIBER POST5013917L05013917L02026-09-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04250337119661Endo-Kerrison ShaftJoimax GmbHLRY2026-10-28
04250337121817Endo-Kerrison ShaftJoimax GmbHLRY2026-10-28
04250337121947PunchJoimax GmbHLRY2026-10-27
B8035903620ORTHOMEDORTHO-MED, INC.LRY2026-10-14
B8035903630ORTHOMEDORTHO-MED, INC.LRY2026-10-14
04063574200210nexoderm® Biopsy Punch Ø 3,0 mmsfm medical devices GmbHLRY2026-09-28
04063574200227nexoderm® Biopsy Punch Ø 4,0 mmsfm medical devices GmbHLRY2026-09-28
04063574200234nexoderm® Biopsy Punch Ø 5,0 mmsfm medical devices GmbHLRY2026-09-28
04063574200241nexoderm® Biopsy Punch Ø 6,0 mmsfm medical devices GmbHLRY2026-09-28
04063574200258nexoderm® Biopsy Punch Ø 8,0 mmsfm medical devices GmbHLRY2026-09-28
04063574200203nexoderm® Biopsy Punch Ø 2,0 mmsfm medical devices GmbHLRY2026-09-21
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