FDA.reportPublic FDA data

DISTRACTION, INTERNAL

Primary DI
00888118136626
Brand
DISTRACTION, INTERNAL
Company
KLS-Martin L.P.
Model
25-025-52-07
Device description
SELECTOR, SPRING, CRANIOXPAND
Published
2023-12-25
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
PBJCranial Distraction System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PBJCranial Distraction SystemNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00888118136626PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00888118136626008881181366268881181366260888118136626

GMDN Terms#

Term, Definition table
TermDefinition
Surgical implant/trial-implant/sizer holder, reusableA hand-held manual surgical instrument designed to connect to and hold an implant (e.g., bone screw, bone graft), trial implant, or implantable device sizer/template (e.g., glenoid defect sizer, hearing implant template) to facilitate guidance, gauging/sizing, and/or monitoring of the held device during orthopaedic or ear/nose/throat (ENT) surgery. The instrument is typically made of metal or synthetic polymer materials and is typically constructed in the form of a long shaft with a handle at the proximal end and a device holding/fixation mechanism at the distal end. 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
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00888118019547FORCEPS13-451-20-072018-09-26
00888118069085PROBE43-736-06-072018-09-26
00888118143037LEVEL ONE THORACIC, STERILE24-015-39-712024-10-08
00888118143044LEVEL ONE THORACIC, STERILE24-015-49-712024-10-08
00888118131782LEVEL ONE EXTREMITY26-066-60-092026-05-25
00888118131799LEVEL ONE EXTREMITY26-066-70-092026-05-25
00888118144928LEVEL ONE EXTREMITY26-950-40-072026-05-25
00888118145284PURE PECTUS24-070-60-092026-05-25
00888118145291PURE PECTUS24-070-62-092026-05-25
00888118150240PURE PECTUSCTM-241-100-012026-05-25
00888118150257PURE PECTUSCTM-241-101-012026-05-25
00888118150264PURE PECTUSCTM-241-200-012026-05-25
00888118150448IXOSCTM-263-100-012026-05-25
00888118150455IXOSCTM-263-101-012026-05-25
00888118150462IXOSCTM-263-202-012026-05-25
00888118150479IXOSCTM-263-202-022026-05-25
00888118150486IXOSCTM-263-202-032026-05-25
00888118150493IXOSCTM-263-202-042026-05-25
00888118150646IPS60-011-42-09-LP2026-05-25
00888118153029L1 STERNALCTM-242-302-012026-05-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00888118149367DISTRACTION, INTERNAL, STERILEKLS-Martin L.P.PBJ2025-09-24
00888118136589DISTRACTION, INTERNALKLS-Martin L.P.PBJ2023-12-25
00888118136596DISTRACTION, INTERNALKLS-Martin L.P.PBJ2023-12-25
00888118136633DISTRACTION, INTERNAL, STERILEKLS-Martin L.P.PBJ2023-12-25
00888118136640DISTRACTION, INTERNAL, STERILEKLS-Martin L.P.PBJ2023-12-25
00888118136657DISTRACTION, INTERNAL, STERILEKLS-Martin L.P.PBJ2023-12-25
10887587071817NASynthes GmbHPBJ2019-12-12
10887587071824NASynthes GmbHPBJ2019-12-12
10887587071831NASynthes GmbHPBJ2019-12-12
10887587071848NASynthes GmbHPBJ2019-12-12
10887587071855NASynthes GmbHPBJ2019-12-12
10887587071923NASynthes GmbHPBJ2019-12-12
10887587071930NASynthes GmbHPBJ2019-12-12
10887587071947NASynthes GmbHPBJ2019-12-12
10887587071954NASynthes GmbHPBJ2019-12-12
10887587072388NASynthes GmbHPBJ2019-12-12
10887587072395NASynthes GmbHPBJ2019-12-12
10887587072401NASynthes GmbHPBJ2019-12-12
10887587072418NASynthes GmbHPBJ2019-12-12
10887587072425NASynthes GmbHPBJ2019-12-12
10887587072517NASynthes GmbHPBJ2019-12-12
10887587072524NASynthes GmbHPBJ2019-12-12
10887587072531NASynthes GmbHPBJ2019-12-12
10887587072548NASynthes GmbHPBJ2019-12-12
10887587072555NASynthes GmbHPBJ2019-12-12
20887587071869NASynthes GmbHPBJ2019-12-12
20887587071876NASynthes GmbHPBJ2019-12-12
20887587071883NASynthes GmbHPBJ2019-12-12
20887587071890NASynthes GmbHPBJ2019-12-12
20887587071906NASynthes GmbHPBJ2019-12-12