FDA.report

Instrapac

Primary DI
05010058081604
Brand
Instrapac
Company
ROBINSON HEALTHCARE LIMITED
Model
8160
Catalog number
8160
Device description
Instrapac McKays Elevator 18cm X 20
Published
2025-06-23
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

Related Records

Contact Domains

Product Codes

CodeName
HTEElevator

Product Code Classifications

CodeDeviceSpecialtyClass
HTEElevatorGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
05010058081604PackageGS120In Commercial Distribution
05010058999701PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05010058081604050100580816045010058081604
05010058999701050100589997015010058999701

GMDN Terms

TermDefinition
General-purpose surgical spatulaA hand-held manual surgical instrument designed to manipulate tissue during various types of surgical interventions. It typically consists of a flat blunt blade (no sharp edges) that is double-ended (a blade at either end) and is not constructed for one particular part of the anatomy or clinical specialty. It is usually made of high-grade stainless steel and is available with a variety of blade designs, e.g., curved and flat or straight and flat with rounded ends; some blade types may be more right-angled. The handle will be formed from its middle section and may be more prominent/serrated. This is a reusable device.

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Keep Dry and Keep Out of Direct Sunlight

Sterilization Methods

Method

Contacts

PhoneEmail
+441909735502ASKVCI@vernacare.com

Regulatory Flags

DUNS number
237799775
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
true
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

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05010058182370Instrapac823782372025-05-22
05010058182387Instrapac823882382025-05-22
05010058182943Instrapac829482942025-05-22
05010058184220Instrapac842284222025-05-22
05010058184800Instrapac848084802025-05-22
05010058184992Instrapac849984992025-05-22
05010058184343Instrapac843484342025-12-16
05010058178885Instrapac788878882025-09-11
05010058179509Instrapac795079502025-09-11
05010058179660Instrapac796679662025-09-11
05010058180963Instrapac809680962025-09-11
05010058181977Instrapac819781972025-09-11
05010058182554Instrapac825582552025-09-11
05010058183605Instrapac836083602025-09-11
05010058184671Instrapac846784672025-09-11
05010058177840Instrapac778477842025-06-25

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00840277133373Innomed, Inc.INNOMED, INC.HTE2026-02-26
00840277133380Innomed, Inc.INNOMED, INC.HTE2026-02-26
00190776416539MillenniumAvalign Technologies, Inc.HTE2026-02-16
03662663109468Mergence-A Preparation InstrumentationHighridge Medical, LLCHTE2026-02-11
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M93072513543B0Life Instruments Life Instrument CorporationHTE2026-02-02
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00840180545119General InstrumentsALPHATEC SPINE, INC.HTE2026-01-29
00840277133151Innomed, Inc.INNOMED, INC.HTE2026-01-16
00840180543313General InstrumentsALPHATEC SPINE, INC.HTE2025-12-31
00840180543320General InstrumentsALPHATEC SPINE, INC.HTE2025-12-31
00840180543337General InstrumentsALPHATEC SPINE, INC.HTE2025-12-31
00840180543344General InstrumentsALPHATEC SPINE, INC.HTE2025-12-31
00840180543351General InstrumentsALPHATEC SPINE, INC.HTE2025-12-31
00840180543368General InstrumentsALPHATEC SPINE, INC.HTE2025-12-31
03662663156905SOLITAIRE CERVICAL SPACER SYSTEMHighridge Medical, LLCHTE2025-12-29
00199150051687Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HTE2025-12-25
00199150051694Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HTE2025-12-25
00199150051700Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HTE2025-12-25
03662663272186Timberline Lateral Fusion SystemHighridge Medical, LLCHTE2025-12-18
03662663272193Timberline Lateral Fusion SystemHighridge Medical, LLCHTE2025-12-18
03662663272209Timberline Lateral Fusion SystemHighridge Medical, LLCHTE2025-12-18
03662663272216Timberline Lateral Fusion SystemHighridge Medical, LLCHTE2025-12-18
03662663272223Timberline Lateral Fusion SystemHighridge Medical, LLCHTE2025-12-18