FDA.report

SHORT ACETABULAR BLADE D50 mm LONG

Primary DI
08057968713383
Brand
SHORT ACETABULAR BLADE D50 mm LONG
Company
HPF SRL
Model
H0050451169
Published
2022-09-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications

CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08057968713383PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08057968713383080579687133838057968713383

GMDN Terms

TermDefinition
Orthopaedic osteotome blade, reusableA sharp component of an orthopaedic osteotome intended to be attached to a dedicated handle (not included) to become a chisel-like surgical instrument designed to cut and/or shape bone by percussion during an orthopaedic procedure. It is typically flat or curved (concave) in design and bevelled on one or both sides; it is made of high-grade stainless steel. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
895802853
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
true
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
08055727370914STRAIGHT HANDLE HC CONN. ZIMMER01.11.10.07012022-09-09
08055727370921STRAIGHT HANDLE NEW HC CONN. ZIMMER01.11.10.07212022-09-09
08055727370938STRAIGHT HANDLE NEW HC CONN. A.O.01.11.10.07002022-09-09
08055727370945STRAIGHT HANDLE NEW HC CONN. A.O.01.11.10.07202022-09-09
08055727370952STRAIGHT HANDLE HC CONN. HUDSON01.11.10.07022022-09-09
08055727370969STRAIGHT HANDLE NEW HC CONN. HUDSON01.11.10.07222022-09-09
08055727371850STRAIGHT HANDLE UNIVERSAL CONN. ZIMMER01.11.10.07112022-09-09
08055727371867STRAIGHT HANDLE UNIVERSAL CONN. A.O.01.11.10.07102022-09-09
08055727371874STRAIGHT HANDLE UNIVERSAL CONN. HUDSON01.11.10.07122022-09-09
08055727372260THIN OSTEOTOME BLADE 76x8 WITH HOLE903000658002022-09-09
08055727372277THIN OSTEOTOME BLADE 76x10 WITH HOLE903000658102022-09-09
08055727372284THIN OSTEOTOME BLADE 76x12 WITH HOLE903000658202022-09-09
08055727372291THIN OSTEOTOME BLADE 76x20 WITH HOLE903000658302022-09-09
08055727372413THIN OSTEOTOME BLADE 127x8 WITH HOLE903000659502022-09-09
08055727372420THIN OSTEOTOME BLADE 127x10 WITH HOLE903000659602022-09-09
08055727372529THIN OSTEOTOME BLADE 76x8 WITH SLOT01.10.10.20552022-09-09
08055727372536THIN OSTEOTOME BLADE 76x10 WITH SLOT01.10.10.20562022-09-09
08055727372543THIN OSTEOTOME BLADE 76x12 WITH SLOT01.10.10.20572022-09-09
08055727372550THIN OSTEOTOME BLADE 76x20 WITH SLOT01.10.10.20582022-09-09
08055727372567THIN OSTEOTOME BLADE 127x8 WITH SLOT01.10.10.20592022-09-09

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00198506090998ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
00198506091001ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
00198506091018ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
00198506091025ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
00198506091032ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
00198506091049ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
00198506091056ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
00198506091063ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
00198506091070ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
00198506091087ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
00841523181360Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-05-26
00841523181681Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-05-26
00841523181698Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-05-26
00841523181704Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-05-26
00841523181711Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-05-26
00841523181728Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-05-26
00841523181735Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-05-26
00841523181742Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-05-26
00841523181759Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-05-26
00841523181766Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-05-26
00841523181773Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-05-26
00841523181780Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-05-26
00841523181797Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-05-26
00841523181803Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-05-26
00841523181810Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-05-26
00841523181827Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-05-26
00841523181834Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-05-26
00841523181841Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-05-26
00841523181858Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-05-26
00841523181865Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-05-26