FDA.reportPublic FDA data

LEVEL ONE EXTREMITY

Primary DI
00888118131614
Brand
LEVEL ONE EXTREMITY
Company
KLS-Martin L.P.
Model
26-166-11-07
Device description
PLIERS, COMPRESSION, RECOS, 30*, LEFT
Published
2026-04-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HTCPLIERS, SURGICAL

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00888118131614PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00888118131614008881181316148881181316140888118131614

GMDN Terms#

Term, Definition table
TermDefinition
Bone fixation plate pliersA manual surgical instrument designed to bend and cut light-bone fixation plates (e.g., 1 to 2 mm in thickness), such as those used in craniomaxillofacial (CMF) or finger surgery. The instrument is typically made of high-grade steel and consists of two arms/rods that form a handle proximally and extend distally through a pivot to form jaws that bend and cut the metal plates allowing the surgeon to customize their size and shape. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

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
00888118150288LEVEL ONE CMF, STERILE50-280-00-712026-10-21
00888118150295LEVEL ONE CMF, STERILE50-280-03-712026-10-21
00888118150301LEVEL ONE CMF, STERILE50-280-05-712026-10-21
00888118150318LEVEL ONE CMF, STERILE50-280-07-712026-10-21
00888118150325LEVEL ONE CMF, STERILE50-280-09-712026-10-21
00888118150332LEVEL ONE CMF, STERILE50-280-11-712026-10-21
00888118150349LEVEL ONE CMF, STERILE50-282-00-712026-10-21
00888118150356LEVEL ONE CMF, STERILE50-282-03-712026-10-21
00888118150363LEVEL ONE CMF, STERILE50-282-05-712026-10-21
00888118150370LEVEL ONE CMF, STERILE50-282-07-712026-10-21
00888118150387LEVEL ONE CMF, STERILE50-282-09-712026-10-21
00888118150394LEVEL ONE CMF, STERILE50-282-11-712026-10-21
00888118150400LEVEL ONE CMF, STERILE50-302-09-712026-10-21
00888118150417LEVEL ONE CMF, STERILE50-302-11-712026-10-21
00888118154910LEVEL ONE CMF25-874-11-612026-10-21
00888118154927LEVEL ONE CMF25-874-11-912026-10-21
00888118154934LEVEL ONE CMF25-874-15-912026-10-21
00888118154941LEVEL ONE CMF25-874-15-612026-10-21
00888118154958LEVEL ONE CMF, STERILE25-874-11-712026-10-21
00888118154965LEVEL ONE CMF, STERILE25-874-15-712026-10-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00724995312169V. MuellerSTERIS Deutschland GmbHHTC2026-09-25
B8034605720ORTHOMEDORTHO-MED, INC.HTC2026-07-14
B8034605730ORTHOMEDORTHO-MED, INC.HTC2026-07-14
B8034605740ORTHOMEDORTHO-MED, INC.HTC2026-07-14
B8034709290ORTHOMEDORTHO-MED, INC.HTC2026-07-14
B8034802540ORTHOMEDORTHO-MED, INC.HTC2026-07-14
B8034802570ORTHOMEDORTHO-MED, INC.HTC2026-07-14
B8034802580ORTHOMEDORTHO-MED, INC.HTC2026-07-14
10887587077628NASynthes GmbHHTC2024-08-21
10840199539458ForcepKOROS U.S.A., INC.HTC2024-02-01
10840199539489ForcepKOROS U.S.A., INC.HTC2024-02-01
10840199535900ClampKOROS U.S.A., INC.HTC2024-01-31
10840199535962C ClampKOROS U.S.A., INC.HTC2024-01-31
10840199535993Aortic ClampKOROS U.S.A., INC.HTC2024-01-31
10840199536006Aortic ClampKOROS U.S.A., INC.HTC2024-01-31
00841435121621TecometTECOMET INC.HTC2023-07-20
14026704799135PILLINGTELEFLEX INCORPORATEDHTC2022-12-08
14026704799142PILLINGTELEFLEX INCORPORATEDHTC2022-12-08
14026704799159PILLINGTELEFLEX INCORPORATEDHTC2022-12-08
14026704799166PILLINGTELEFLEX INCORPORATEDHTC2022-12-08
14026704799319PILLINGTELEFLEX INCORPORATEDHTC2022-12-08
14026704799326PILLINGTELEFLEX INCORPORATEDHTC2022-12-08
14026704811448PILLINGTELEFLEX INCORPORATEDHTC2022-12-08
10840199539830ForcepsKOROS U.S.A., INC.HTC2022-10-31
10840199539847ForcepsKOROS U.S.A., INC.HTC2022-10-31
10840199539854ForcepsKOROS U.S.A., INC.HTC2022-10-31
10840199539861ForcepsKOROS U.S.A., INC.HTC2022-10-31
10840199539878ForcepsKOROS U.S.A., INC.HTC2022-10-31
10840199539885ForcepsKOROS U.S.A., INC.HTC2022-10-31
10840199539892ForcepsKOROS U.S.A., INC.HTC2022-10-31