FDA.reportPublic FDA data

CURETTE

Primary DI
00888118006974
Brand
CURETTE
Company
KLS-Martin L.P.
Model
01-500-01-07
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
KBJCURETTE, ADENOID

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KBJCurette, AdenoidEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00888118006974PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00888118006974008881180069748881180069740888118006974

GMDN Terms#

Term, Definition table
TermDefinition
Laryngeal knifeA hand-held manual surgical instrument designed to cut and dissect laryngeal tissue, including the vocal cords, during ear/nose/throat (ENT) surgery. It is typically a one-piece instrument made of high-grade stainless steel with a long, slender shaft with a handle at the proximal end and a sharp, single-edged, cutting blade at the distal end. The blade is normally small and available in various shapes (e.g., sickle, flap, straight) according to the procedure performed (e.g., excision of cysts, adhesions, webs). 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
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
00888118086037SILICONE MAT55-348-01-012020-06-19
00888118125729TRAY55-804-25-012020-06-19
00888118003119CARRIER00-105-92-072018-09-26
00888118006981CURETTE01-500-02-072018-09-26
00888118006998CURETTE01-500-03-072018-09-26
00888118008626CALIPER04-407-20-072018-09-26
00888118009012SCOPE HOLDER ARM07-001-42-072016-09-20
00888118009029SCOPE HOLDER CLAMP07-001-43-072016-09-20
00888118009050SCOPE HOLDER ARM07-001-49-072016-09-20
00888118022950PHLEBEXTRACTOR16-249-02-072018-09-26
00888118022967PHLEBEXTRACTOR16-249-03-072018-09-26
00888118022981STRIPPER16-251-02-012018-09-26
00888118022998STRIPPER16-251-03-012018-09-26
00888118023001STRIPPER16-251-04-012018-09-26
00888118023018STRIPPER16-251-06-012018-09-26
00888118023025STRIPPER16-251-07-012018-09-26
00888118023032STRIPPER16-251-08-012018-09-26
00888118023049STRIPPER16-251-10-012018-09-26
00888118023056STRIPPER16-251-14-012018-09-26
00888118023063STRIPPER16-251-30-012018-09-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00724995271817V. MuellerSTERIS Deutschland GmbHKBJ2026-09-25
05060411984127Beckmann Adenoid Curette, 10mm Curette Edge, 220mmDTR MEDICAL LIMITEDKBJ2026-06-10
05060411984141Beckmann Adenoid Curette, 13mm Curette Edge, 220mmDTR MEDICAL LIMITEDKBJ2026-06-10
05060411984165Beckmann Adenoid Curette, 15mm Curette Edge, 220mmDTR MEDICAL LIMITEDKBJ2026-06-10
05060411984189Beckmann Adenoid Curette, 17mm Curette Edge, 220mmDTR MEDICAL LIMITEDKBJ2026-06-10
00194613048723MSI Precision Specialty InstrumentsMed Saver, Inc.KBJ2025-08-01
00194613048730MSI Precision Specialty InstrumentsMed Saver, Inc.KBJ2025-08-01
00194613048747MSI Precision Specialty InstrumentsMed Saver, Inc.KBJ2025-08-01
00194613048754MSI Precision Specialty InstrumentsMed Saver, Inc.KBJ2025-08-01
00194613048778MSI Precision Specialty InstrumentsMed Saver, Inc.KBJ2025-08-01
00194613048792MSI Precision Specialty InstrumentsMed Saver, Inc.KBJ2025-08-01
00194613048808MSI Precision Specialty InstrumentsMed Saver, Inc.KBJ2025-08-01
00194613048822MSI Precision Specialty InstrumentsMed Saver, Inc.KBJ2025-08-01
00194613048839MSI Precision Specialty InstrumentsMed Saver, Inc.KBJ2025-08-01
00194613048846MSI Precision Specialty InstrumentsMed Saver, Inc.KBJ2025-08-01
00194613048877MSI Precision Specialty InstrumentsMed Saver, Inc.KBJ2025-08-01
00194613057329MSI Precision Specialty InstrumentsMed Saver, Inc.KBJ2025-08-01
00194613068820MSI Precision Specialty InstrumentsMed Saver, Inc.KBJ2025-08-01
00194613124014MSI Precision Specialty InstrumentsMed Saver, Inc.KBJ2025-08-01
04049047340003GimmiGimmi GmbHKBJ2025-05-22
04049047340010GimmiGimmi GmbHKBJ2025-05-22
04049047340027GimmiGimmi GmbHKBJ2025-05-22
04049047340034GimmiGimmi GmbHKBJ2025-05-22
04049047371595GimmiGimmi GmbHKBJ2025-05-22
04049047371601GimmiGimmi GmbHKBJ2025-05-22
04049047385509GimmiGimmi GmbHKBJ2025-05-22
04049047385516GimmiGimmi GmbHKBJ2025-05-22
04049047387497GimmiGimmi GmbHKBJ2025-05-22
00194613048709MSI Precision Specialty InstrumentsMed Saver, Inc.KBJ2025-03-21
00194613048716MSI Precision Specialty InstrumentsMed Saver, Inc.KBJ2025-03-21