FDA.reportPublic FDA data

GUIDE PIN/SCREW

Primary DI
E226049312YT1
Brand
GUIDE PIN/SCREW
Company
Gebr. Brasseler GmbH & Co. KG
Model
800-02-505
Catalog number
800-02-505
Published
2018-07-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
HWCScrew, Fixation, Bone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWCScrew, Fixation, BoneOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K131264000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K131264000KOMET MEDICAL KIRSCHNER WIRES, STEINMANN PINS AND GUIDE PINS AND SCREWSGebr. Brasseler GmbH & Co. KG2013-07-26HWC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
24053613208943PackageGS11In Commercial Distribution
14053613208946PrimaryGS10
E226049312YT1SecondaryHIBCC0
84053613208945Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2405361320894324053613208943
1405361320894614053613208946
8405361320894584053613208945

GMDN Terms#

Term, Definition table
TermDefinition
Intraoperative bone pin/screw, sterileA small sterile rod intended to be inserted into bone to temporarily anchor a surgical instrument (e.g., retractor, implant aligner) to bone during an orthopaedic surgical procedure; it is not left in situ after the procedure. It may be wholly- or partially-threaded for screwing into bone, and may have other physical features to enable fixation of surgical instruments. It is made of metallic (e.g., stainless steel) or polymer (radiolucent) material and is available in various shapes and sizes. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
317409001
Device count
2
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
14053613296431Bur, Round, round shank08227360082273602026-05-04
14053613296646Bur, Round, round shank08227570082275702026-05-04
14053613295892Bur, Egg / egg shaped, round shank08227310082273102026-04-28
14053613296004Bur, Round, round shank08226860082268602026-04-28
14053613296325Bur, cylindrical, round shank08227240082272402026-04-28
14053613296363Bur, Bud / bud shaped, round shank08227280082272802026-04-28
14053613296455Bur, Round, round shank08227380082273802026-04-28
14053613296639Bur, Round, round shank08227560082275602026-04-28
14053613296684Twist drill, round shank08227620082276202026-04-28
14053613297438Bur, Round, round shank08228390082283902026-04-28
14053613297469Bur, Round, round shank08226770082267702026-04-28
14053613296561Bur, Round, round shank08227490082274902026-04-24
14053613296707Twist drill, round shank08227640082276402026-04-24
14053613295830Bur, Round, round shank08223830082238302026-04-21
14053613295878Bur, Round, round shank08226760082267602026-04-21
14053613295885Bur, Egg / egg shaped, round shank08227060082270602026-04-21
14053613295946Bur, Round, round shank08226800082268002026-04-21
14053613295953Bur, Round, round shank08226810082268102026-04-21
14053613295984Bur, Round, round shank08226840082268402026-04-21
14053613296035Bur, Round, round shank08226890082268902026-04-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00841731140449ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140456ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140463ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140470ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140487ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140494ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140500ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140517ARTEMIS FUZEVILEX LLCHWC2026-07-22
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00841731140531ARTEMIS FUZEVILEX LLCHWC2026-07-22
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00841731140555ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140562ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140593ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140609ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140616ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140623ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140630ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140647ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140654ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140661ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140678ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140685ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140692ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140708ARTEMIS FUZEVILEX LLCHWC2026-07-22