FDA.reportPublic FDA data

SAMPEDRO

Primary DI
07708626670715
Brand
SAMPEDRO
Company
INDUSTRIAS MEDICAS SAMPEDRO S A S
Model
0
Catalog number
/B25195
Device description
Drill Bit φ2.5
Published
2022-05-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
HTWBit, Drill

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTWBit, DrillOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07708626670715PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07708626670715077086266707157708626670715

GMDN Terms#

Term, Definition table
TermDefinition
Fluted surgical drill bit, reusableA shaft of metal with an obtuse, V-shaped cutting edge designed to be rotated to bore into bone to create a hole of the same dimension as the diameter of the shaft. This device, commonly called a "twist drill", has a cylindrical design with a double-edged cutting head that is formed from two spiralled flutes that extend the length of the insertion part of the drill. At the proximal end, it is usually inserted into a surgical power tool or a surgical hand drill/brace. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
880314190
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07708626670869SAMPEDRO0/IMP62022-05-12
07708604560892SAMPEDRO0/GAFF2022-05-12
07708626670081SAMPEDRO0/DPGD-W42022-05-12
07708626670289SAMPEDRO0/DPGI-W42022-05-12
07708626670159SAMPEDRO0/SH242022-05-12
07708626670906SAMPEDRO0/SH2852022-05-12
07708604560397SAMPEDRO0TCIAT35162023-02-14
07708604560564SAMPEDRO0TBPA35122023-02-14
07708604560595SAMPEDRO0TCIAT35122023-02-14
07708604560724SAMPEDRO0TBPA35102023-02-14
07708604560779SAMPEDRO0TCIAT35102023-02-14
07708604560885SAMPEDRO0TBPA35142023-02-14
07708604560915SAMPEDRO0TCIAT35142023-02-14
07708604560922SAMPEDRO0TBPA35162023-02-14
07708434060579SAMPEDRO0TCIAT35652022-05-12
07708434060586SAMPEDRO0TCIAT35502022-05-12
07708434060722SAMPEDRO0TCIAT35552022-05-12
07708434060944SAMPEDRO0TCIAT35602022-05-12
07708604560021SAMPEDRO0TBPA35242022-05-12
07708604560052SAMPEDRO0TCIAT35202022-05-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10886982345431VOLTSynthes GmbHHTW2026-09-25
10886982345479VOLTSynthes GmbHHTW2026-09-25
00888867574540Arthrex®ARTHREX, INC.HTW2026-09-18
00888867574557Arthrex®ARTHREX, INC.HTW2026-09-18
10810128463079OSSIO® Threaded Trimmable Fixation Nail Instrument Pack W Drill Bit 7.0x70mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONHTW2026-08-23
10810128463086OSSIO® Threaded Trimmable Fixation Nail Instrument Pack W Drill Bit 7.0x100mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONHTW2026-08-23
10810128463185OSSIO® Threaded Trimmable Fixation Nail Instrument Pack 7.0x70mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONHTW2026-08-23
10810128463192OSSIO® Threaded Trimmable Fixation Nail Instrument Pack 7.0x100mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONHTW2026-08-23
00884450681381Preston™Merit Medical Systems, Inc.HTW2026-08-21
00884450681398Preston™Merit Medical Systems, Inc.HTW2026-08-21
00840606191791Overwatch PCFSPINAL ELEMENTS, INC.HTW2026-07-31
00840606191807Overwatch PCFSPINAL ELEMENTS, INC.HTW2026-07-31
00840606191814Overwatch PCFSPINAL ELEMENTS, INC.HTW2026-07-31
00840606191821Overwatch PCFSPINAL ELEMENTS, INC.HTW2026-07-31
00840606191852Overwatch PCFSPINAL ELEMENTS, INC.HTW2026-07-31
00840606195768Overwatch PCFSPINAL ELEMENTS, INC.HTW2026-07-31
00840606195775Overwatch PCFSPINAL ELEMENTS, INC.HTW2026-07-31
00190376544397InvictusALPHATEC SPINE, INC.HTW2026-07-30
00190376544403InvictusALPHATEC SPINE, INC.HTW2026-07-30
00190376544410InvictusALPHATEC SPINE, INC.HTW2026-07-30
00190376544427InvictusALPHATEC SPINE, INC.HTW2026-07-30
00190376544434InvictusALPHATEC SPINE, INC.HTW2026-07-30
00190376544441InvictusALPHATEC SPINE, INC.HTW2026-07-30
00190376544458InvictusALPHATEC SPINE, INC.HTW2026-07-30
00190376544465InvictusALPHATEC SPINE, INC.HTW2026-07-30
00190376544472InvictusALPHATEC SPINE, INC.HTW2026-07-30
00190376544489InvictusALPHATEC SPINE, INC.HTW2026-07-30
00190376544861InvictusALPHATEC SPINE, INC.HTW2026-07-30
00190376544878InvictusALPHATEC SPINE, INC.HTW2026-07-30
03701089515153AMPLITUDEAMPLITUDE SASHTW2026-07-29