FDA.reportPublic FDA data

PHLEBEXTRACTOR

Primary DI
00888118022967
Brand
PHLEBEXTRACTOR
Company
KLS-Martin L.P.
Model
16-249-03-07
Device description
VARADY
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
GAISTRIPPER, VEIN, REUSABLE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GAIStripper, Vein, ReusableGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00888118022967PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00888118022967008881180229678881180229670888118022967

GMDN Terms#

Term, Definition table
TermDefinition
Open-surgery dissectorA hand-held surgical instrument, usually spoon-shaped or rounded at the working end, used to separate a soft tissue or body structure from another. It is used in general or plastic surgery and is usually designed with a handle which continues into a shaft that terminates at the distal end with a tip. The tip may be pointed or flat, sharp or blunt, and angled or straight from the shaft. It is made of high-grade stainless steel, comes in various shapes and sizes. 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
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
00888118006974CURETTE01-500-01-072018-09-26
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
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
G141520426040Carnegie Surgical LLCCarnegie Surgical LLCGAI2026-09-30
05055445928162SurtexSURTEX INSTRUMENTS LTD.GAI2026-05-12
05055445928179SurtexSURTEX INSTRUMENTS LTD.GAI2026-05-12
05055445928186SurtexSURTEX INSTRUMENTS LTD.GAI2026-05-12
05055445928193SurtexSURTEX INSTRUMENTS LTD.GAI2026-05-12
05055445928209SurtexSURTEX INSTRUMENTS LTD.GAI2026-05-12
05055445928216SurtexSURTEX INSTRUMENTS LTD.GAI2026-05-12
05055445928223SurtexSURTEX INSTRUMENTS LTD.GAI2026-05-12
05055445928230SurtexSURTEX INSTRUMENTS LTD.GAI2026-05-12
05055445928247SurtexSURTEX INSTRUMENTS LTD.GAI2026-05-12
05055445928254SurtexSURTEX INSTRUMENTS LTD.GAI2026-05-12
05055445928261SurtexSURTEX INSTRUMENTS LTD.GAI2026-05-12
05055445928407SurtexSURTEX INSTRUMENTS LTD.GAI2026-05-12
05055445928414SurtexSURTEX INSTRUMENTS LTD.GAI2026-05-12
05055445928421SurtexSURTEX INSTRUMENTS LTD.GAI2026-05-12
05055445928438SurtexSURTEX INSTRUMENTS LTD.GAI2026-05-12
05055445928445SurtexSURTEX INSTRUMENTS LTD.GAI2026-05-12
05055445928452SurtexSURTEX INSTRUMENTS LTD.GAI2026-05-12
00190776406523MillenniumAvalign Technologies, Inc.GAI2025-07-22
00190776406530MillenniumAvalign Technologies, Inc.GAI2025-07-22
00190776406547MillenniumAvalign Technologies, Inc.GAI2025-07-22
00190776393328MillenniumAvalign Technologies, Inc.GAI2025-05-06
00190776393762MillenniumAvalign Technologies, Inc.GAI2025-05-06
08403207004444Anmuth Medical InternationalAnmuth Medical International, LLCGAI2024-07-01
08403207004451Anmuth Medical InternationalAnmuth Medical International, LLCGAI2024-07-01
08403207004468Anmuth Medical InternationalAnmuth Medical International, LLCGAI2024-07-01
00840183505974BR Surgical, LLCBR Surgical, LLCGAI2024-06-03
00840183510206BR Surgical, LLCBR Surgical, LLCGAI2024-06-03
00840183510312BR Surgical, LLCBR Surgical, LLCGAI2024-06-03
00840183514204BR Surgical, LLCBR Surgical, LLCGAI2024-06-03