FDA.reportPublic FDA data

CALIPER

Primary DI
00888118008626
Brand
CALIPER
Company
KLS-Martin L.P.
Model
04-407-20-07
Device description
BUCHMAN
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
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
KTZCALIPER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KTZCaliperOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00888118008626PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00888118008626008881180086268881180086260888118008626

GMDN Terms#

Term, Definition table
TermDefinition
Surgical soft-tissue manipulation forceps, scissors-like, reusableA hand-held, manual, open-surgery instrument designed to grasp, manipulate, dissect, and/or clamp soft-tissues (e.g., organs, blood vessels); it is not intended for grasping/clamping bone or teeth, nor is it dedicated to ophthalmic surgery and is not a dedicated biopsy device. It has a scissors-like hinged design with ring handles and blades (non-cutting) that may be available in a range of sizes or designs. It may be intended for use at a specific anatomy. This is a reusable device intended to be sterilized prior to use.

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
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
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
00840180545706General InstrumentsALPHATEC SPINE, INC.KTZ2026-05-15
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00840343727338GEN2SURGIX MEDICAL LLCKTZ2026-04-16
09348811099037INKAThe Trustee for KAISER FAMILY TRUSTKTZ2026-04-10
09348811099044INKAThe Trustee for KAISER FAMILY TRUSTKTZ2026-03-18
00840311245680Streamline® MIS Spinal Fixation SystemXtant Medical Holdings, Inc.KTZ2026-03-18
G079C5080000100MIS Golden Isles Pedicle Screw System Intelivation, LLCKTZ2026-01-30
00840180545287General InstrumentsALPHATEC SPINE, INC.KTZ2026-01-29
00190376680408ProximityALPHATEC SPINE, INC.KTZ2025-12-19
03662663244701Vital MIS Spinal Fixation SystemHighridge Medical, LLCKTZ2025-12-18
03662663244800Vital MIS Spinal Fixation SystemHighridge Medical, LLCKTZ2025-12-18
00887868457180Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCKTZ2025-11-14
00888480500834Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCKTZ2025-11-14
03662663131957Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCKTZ2025-11-14
03662663194020PathFinder NXT Minimally Invasive Pedicle Screw SystemHighridge Medical, LLCKTZ2025-11-14
03662663194037PathFinder NXT Minimally Invasive Pedicle Screw SystemHighridge Medical, LLCKTZ2025-11-14
03662663109925InViZia Anterior Cervical Plate SystemHighridge Medical, LLCKTZ2025-11-12
03662663126137Vital Spinal Fixation SystemHighridge Medical, LLCKTZ2025-11-07
00763000684112N/AMEDTRONIC SOFAMOR DANEK, INC.KTZ2025-09-08
00194613115111MSI Precision Specialty InstrumentsMed Saver, Inc.KTZ2025-08-01
00190376585628InvictusALPHATEC SPINE, INC.KTZ2025-05-01
04719886908275USTAR II Knee SystemUNITED ORTHOPEDIC CORP.KTZ2025-04-30
00194613050023MSI Precision Specialty InstrumentsMed Saver, Inc.KTZ2025-03-21
00194613081515MSI Precision Specialty InstrumentsMed Saver, Inc.KTZ2025-03-21
00763000864675n/aMEDTRONIC SOFAMOR DANEK, INC.KTZ2025-03-11
09421028119290Kinematic Alignment Caliper – S+NENZTEC LIMITEDKTZ2025-01-24
00840306823749Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.KTZ2025-01-17
00840306823756Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.KTZ2025-01-17
00840306823831Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.KTZ2025-01-17
00840306821509Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.KTZ2025-01-16