FDA.reportPublic FDA data

SAW

Primary DI
00888118060198
Brand
SAW
Company
KLS-Martin L.P.
Model
37-631-20-07
Device description
NASAL, JOSEPH, LEFT
Published
2018-09-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KBCSAW, NASAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KBCSaw, NasalEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00888118060198PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00888118060198008881180601988881180601980888118060198

GMDN Terms#

Term, Definition table
TermDefinition
Manual surgical saw, flexibleA hand-held manual surgical instrument typically used in orthopaedic or neurological surgery for cutting bone through a sawing action performed by the operator. It typically consists of an exchangeable, flexible, wire-like blade with a handle at each end of the blade. The handles can be easily unhooked to permit entry of the blade into a narrow opening, e.g., holes drilled in the top of the skull through which the flexible blade is fed for sawing of the skull prior to removal of the top section. This device is commonly known as a Gigli saw. 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
00888118145819IPS60-011-13-09-LP2026-10-01
00888118145826IPS60-011-14-09-LP2026-10-01
00888118145833IPS60-011-15-09-LP2026-10-01
00888118145840IPS60-011-16-09-LP2026-10-01
00888118145857IPS60-011-17-09-LP2026-10-01
00888118145864IPS60-011-18-09-LP2026-10-01
00888118036261LEVEL ONE CMF25-038-30-092016-03-24
00888118036278LEVEL ONE CMF25-038-35-092016-03-24
00888118036285LEVEL ONE NEURO25-040-25-092016-03-24
00888118036292LEVEL ONE NEURO, STERILE25-040-25-712016-03-23
00888118036339LEVEL ONE CMF25-040-35-092016-03-24
00888118036346LEVEL ONE CMF25-040-40-092016-03-24
00888118036360LEVEL ONE NEURO25-042-02-092016-03-24
00888118036391LEVEL ONE NEURO25-042-05-092016-03-24
00888118036483LEVEL ONE CMF, STERILE25-042-20-712016-03-23
00888118092618LEVEL ONE CMF25-043-06-092016-03-24
00888118155498IPS60-500-15-092026-09-28
00888118155504IPS60-500-15-09-LP2026-09-28
00888118155511IPS60-500-15-09-PP2026-09-28
00888118155528IPS60-500-17-092026-09-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G586E7871320Novo SurgicalNOVO SURGICAL, INC.KBC2023-12-18
G586E7871330Novo SurgicalNOVO SURGICAL, INC.KBC2023-12-18
G586E97871210Novo SurgicalNOVO SURGICAL, INC.KBC2023-12-18
G586E97871220Novo SurgicalNOVO SURGICAL, INC.KBC2023-12-18
G586E97871230Novo SurgicalNOVO SURGICAL, INC.KBC2023-12-18
G586E97871320Novo SurgicalNOVO SURGICAL, INC.KBC2023-12-18
G586E97871330Novo SurgicalNOVO SURGICAL, INC.KBC2023-12-18
00840319753804Hayden MedicalHayden Medical, Inc.KBC2023-10-20
G4252005020My MedicalMy Medical Store LLCKBC2023-08-27
00192896114708Wellenschliff Nasal SawSONTEC INSTRUMENTS, INC.KBC2023-04-28
00842331174797Novo Surgical Inc. NOVO SURGICAL, INC.KBC2022-11-14
00842331158032Novo Surgical Inc. NOVO SURGICAL, INC.KBC2022-11-12
00842331130250Novo Surgical Inc. NOVO SURGICAL, INC.KBC2022-11-10
00840329807320N/ABLACK & BLACK SURGICAL, INC.KBC2022-09-21
00840329807337N/ABLACK & BLACK SURGICAL, INC.KBC2022-09-21
00840329807344N/ABLACK & BLACK SURGICAL, INC.KBC2022-09-21
B089B621500N/ABLACK & BLACK SURGICAL, INC.KBC2022-09-12
B089B621510N/ABLACK & BLACK SURGICAL, INC.KBC2022-09-12
B089B621520N/ABLACK & BLACK SURGICAL, INC.KBC2022-09-12
00840319722008Hayden MedicalHayden Medical, Inc.KBC2022-08-08
00840319722015Hayden MedicalHayden Medical, Inc.KBC2022-08-08
00840319707043Hayden MedicalHayden Medical, Inc.KBC2022-07-27
00840319707074Hayden MedicalHayden Medical, Inc.KBC2022-07-27
00840319707081Hayden MedicalHayden Medical, Inc.KBC2022-07-27
04046826472221MediconMedicon eG. Chirurgiemechaniker-GenossenschaftKBC2020-09-24
04046826472238MediconMedicon eG. Chirurgiemechaniker-GenossenschaftKBC2020-09-24
04046826116170MediconMedicon eG. Chirurgiemechaniker-GenossenschaftKBC2020-09-24
04046826116187MediconMedicon eG. Chirurgiemechaniker-GenossenschaftKBC2020-09-24
04046826116194MediconMedicon eG. Chirurgiemechaniker-GenossenschaftKBC2020-09-24
04046826116200MediconMedicon eG. Chirurgiemechaniker-GenossenschaftKBC2020-09-24