Hyper-C

Primary DI: 00842048152255
Brand: Hyper-C
Company: DEGEN MEDICAL, INC.
Model: 02-27P
Catalog number: 02-27P
Device description: Fixation Pin Cervical Spacer
Published: 2022-08-22
Public version status: New
Distribution status: In Commercial Distribution
MRI safety: Labeling does not contain MRI Safety Information
Rx: true
OTC: false
Sterile: false
Single use: false

Related Records

Contact Domains

degenmedical.com

Product Codes

Code	Name
LXH	Orthopedic manual surgical instrument

Product Code Classifications

Code	Device	Specialty	Class
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	1

Identifiers And Packaging

Identifier	Type	Agency	Package quantity	Status
00842048152255	Primary	GS1	0

Alternate GTIN / UPC / EAN Codes

Source identifier	GTIN-14 normalized	UPC-A	EAN-13
00842048152255	00842048152255	842048152255	0842048152255

GMDN Terms

Term	Definition
Orthopaedic bone screw starter/notcher	A hand-held surgical instrument used to create an indentation or enlarge a pre-drilled pilot hole in a bone that will enable the surgeon to begin threading a bone screw or place another form of anchoring device. This device, commonly known as a bone notcher, may function and be used in a variety of ways: 1) notch the bone such that the threads on a bone screw will bite into the bone; 2) simply hold the screw at the desired angle to the bone while the screw is driven into position; or 3) in the case of hard bone (e.g., on the glenoid) be inserted into a pilot hole where it is rotated to create a cavity within the soft bone for placement of, e.g., a suture anchor. This is a reusable device.

Term

Definition

Orthopaedic bone screw starter/notcher

A hand-held surgical instrument used to create an indentation or enlarge a pre-drilled pilot hole in a bone that will enable the surgeon to begin threading a bone screw or place another form of anchoring device. This device, commonly known as a bone notcher, may function and be used in a variety of ways: 1) notch the bone such that the threads on a bone screw will bite into the bone; 2) simply hold the screw at the desired angle to the bone while the screw is driven into position; or 3) in the case of hard bone (e.g., on the glenoid) be inserted into a pilot hole where it is rotated to create a cavity within the soft bone for placement of, e.g., a suture anchor. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

Phone	Email
+1(877)240-7838	customerservice@degenmedical.com

Regulatory Flags

DUNS number: 078812602
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

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00842048182726	Latitude-C AM™ Cervical Interbody Fusion System	0306-161405L04	0306-161405L04	2025-11-24
00842048182733	Latitude-C AM™ Cervical Interbody Fusion System	0306-161406L04	0306-161406L04	2025-11-24
00842048182740	Latitude-C AM™ Cervical Interbody Fusion System	0306-161407L04	0306-161407L04	2025-11-24
00842048182757	Latitude-C AM™ Cervical Interbody Fusion System	0306-161408L04	0306-161408L04	2025-11-24
00842048182764	Latitude-C AM™ Cervical Interbody Fusion System	0306-161409L04	0306-161409L04	2025-11-24
00842048182771	Latitude-C AM™ Cervical Interbody Fusion System	0306-161410L04	0306-161410L04	2025-11-24
00842048182788	Latitude-C AM™ Cervical Interbody Fusion System	0306-161411L04	0306-161411L04	2025-11-24
00842048182795	Latitude-C AM™ Cervical Interbody Fusion System	0306-161412L04	0306-161412L04	2025-11-24
00842048182801	Latitude-C AM™ Cervical Interbody Fusion System	0306-161413L04	0306-161413L04	2025-11-24
00842048182818	Latitude-C AM™ Cervical Interbody Fusion System	0306-161414L04	0306-161414L04	2025-11-24
00842048182979	Latitude-C AM™ Cervical Interbody Fusion System	0306-181410L04	0306-181410L04	2025-11-24
00842048182986	Latitude-C AM™ Cervical Interbody Fusion System	0306-181411L04	0306-181411L04	2025-11-24
00842048182993	Latitude-C AM™ Cervical Interbody Fusion System	0306-181412L04	0306-181412L04	2025-11-24
00842048183006	Latitude-C AM™ Cervical Interbody Fusion System	0306-181413L04	0306-181413L04	2025-11-24
00842048183013	Latitude-C AM™ Cervical Interbody Fusion System	0306-181414L04	0306-181414L04	2025-11-24
00842048183327	Latitude-C AM™ Cervical Interbody Fusion System	0306-121205L08	0306-121205L08	2025-11-24
00842048183334	Latitude-C AM™ Cervical Interbody Fusion System	0306-121206L08	0306-121206L08	2025-11-24
00842048183341	Latitude-C AM™ Cervical Interbody Fusion System	0306-121207L08	0306-121207L08	2025-11-24
00842048183358	Latitude-C AM™ Cervical Interbody Fusion System	0306-121208L08	0306-121208L08	2025-11-24
00842048183365	Latitude-C AM™ Cervical Interbody Fusion System	0306-121209L08	0306-121209L08	2025-11-24

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