FDA.report

REDUCTION INSTRUMENT

Primary DI
00888118063243
Brand
REDUCTION INSTRUMENT
Company
KLS-Martin L.P.
Model
38-708-00-07
Published
2018-09-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Product Code Classifications

CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00888118063243PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00888118063243008881180632438881180632430888118063243

GMDN Terms

TermDefinition
Orthopaedic bone-fragment manipulator, single-use, non-sterileA non-sterile, hand-held manual surgical instrument designed to help position a fractured fragment of bone to achieve proper alignment (reduction). It is typically a long, thin, rigid rod made of high-grade stainless steel with a self-drilling/self-tapping screw thread at the distal end and a connector at the proximal end to attach an appropriate handle. The device is usually inserted transcutaneously to the fractured section of bone (e.g., through the cheek and into the mandible) and removed after positioning and fixation of the fracture. This is a single-use device intended to be sterilized prior to use.

Device Sizes

TypeValueUnit
Device Size Text, specify0

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

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 DIBrandModelCatalogPublished
00888118143266PURE PECTUS24-070-40-092026-03-23
00888118143273PURE PECTUS24-070-42-092026-03-23
00888118143280PURE PECTUS24-070-44-092026-03-23
00888118143297PURE PECTUS24-070-46-092026-03-23
00888118143303PURE PECTUS24-070-48-092026-03-23
00888118143310PURE PECTUS24-070-50-092026-03-23
00888118143327PURE PECTUS24-071-40-092026-03-23
00888118143334PURE PECTUS24-071-42-092026-03-23
00888118143341PURE PECTUS24-071-44-092026-03-23
00888118143358PURE PECTUS24-071-46-092026-03-23
00888118143365PURE PECTUS24-071-48-092026-03-23
00888118143372PURE PECTUS24-071-50-092026-03-23
00888118145321PURE PECTUS24-070-50-892026-03-23
00888118145338PURE PECTUS24-071-50-892026-03-23
00888118149671LEVEL ONE CMF, STERILE25-882-06-712026-03-23
00888118149701LEVEL ONE CMF, STERILE25-883-17-712026-03-23
00888118149718LEVEL ONE CMF, STERILE25-883-19-712026-03-23
00888118149725LEVEL ONE CMF, STERILE25-887-17-712026-03-23
00888118149732LEVEL ONE CMF, STERILE25-887-19-712026-03-23
00888118149749LEVEL ONE CMF, STERILE25-889-09-712026-03-23

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