FDA.reportPublic FDA data

PUNCH

Primary DI
00888118119773
Brand
PUNCH
Company
KLS-Martin L.P.
Model
99-591-23-01
Published
2018-09-26
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GXJPUNCH, SKULL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GXJPunch, SkullNeurology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00888118119773PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00888118119773008881181197738881181197730888118119773

GMDN Terms#

Term, Definition table
TermDefinition
Bone-coring punch, reusableA hand-held manual surgical instrument designed to cut out (core) sections of bone during surgery. It consists of a handle and a cylindrical distal tip which has a bevelled, sharp cutting edge, which when pressed into the bone and gently rotated will penetrate and cut through the bone allowing that section to be removed. It is and is available in various cutting head sizes, and is not primarily intended for soft-tissue coring. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(904)641-7746KLS-UDI-Info@klsmartin.com

Regulatory Flags#

DUNS number
826499238
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00888118126528LEVEL ONE CMF, STERILE50-774-24-712020-04-22
00888118006530LEVEL ONE CMF01-405-08-092016-03-24
00888118034717LEVEL ONE CMF25-001-13-092016-03-24
00888118034731LEVEL ONE CMF25-002-13-092016-03-24
00888118034748LEVEL ONE CMF25-003-02-092016-03-24
00888118034816LEVEL ONE NEURO, STERILE25-003-10-712016-03-23
00888118034915LEVEL ONE NEURO25-003-21-092016-03-24
00888118035028LEVEL ONE NEURO25-005-12-092016-03-24
00888118035042LEVEL ONE CMF25-006-09-092016-03-24
00888118035721LEVEL ONE CMF25-010-03-092016-03-24
00888118035752LEVEL ONE CMF25-010-08-092016-03-24
00888118035882LEVEL ONE NEURO25-015-04-092016-03-24
00888118035912LEVEL ONE NEURO25-015-06-092016-03-24
00888118035943LEVEL ONE NEURO25-015-08-092016-03-24
00888118035974LEVEL ONE NEURO25-016-06-092016-03-24
00888118036018LEVEL ONE NEURO25-016-10-092016-03-24
00888118036049LEVEL ONE CMF25-017-04-092016-03-24
00888118036056LEVEL ONE CMF25-017-06-092016-03-24
00888118036063LEVEL ONE CMF25-017-08-092016-03-24
00888118036148LEVEL ONE CMF25-020-24-092016-03-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04038653163090AESCULAPAesculap AGGXJ2020-06-17
04038653436880AESCULAPAesculap AGGXJ2020-06-17
00888118119056PUNCHKLS-Martin L.P.GXJ2018-09-26