FDA.reportPublic FDA data

Galea Elevator

Primary DI
00866614000115
Brand
Galea Elevator
Company
ARKIS BIOSCIENCES INC.
Model
41.312.101
Catalog number
41.312.101
Device description
The Galea Elevator is a stainless-steel, reusable, manual surgical instrument designed to retract and elevate scalp tissue.
Published
2019-04-25
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GADRetractor

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GADRetractorGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00866614000115PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00866614000115008666140001158666140001150866614000115

GMDN Terms#

Term, Definition table
TermDefinition
Hand-held surgical retractor, reusableA hand-held, non-self-retaining surgical instrument intended to be used to separate/draw aside the margins of a wound/incision to allow access to tissues/organs during open surgery; it is not dedicated to ophthalmic surgery or small nerve/vessel retraction, but may otherwise be clinically dedicated. It includes a shaped/hooked blade with a handle/holding portion and is available in a wide variety of designs, such as a double- or single-ended blade that may be fenestrated (pronged); deep wound retractors are typically designed with a long, curved blade that may also be intended to retract organs; it may include a light. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
8442475383info@arkisbiosciences.com
+1(800)654-2873custserv@integralife.com

Regulatory Flags#

DUNS number
078846878
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10866614000181Subcutaneous Guidewire - Medium41.240.50241.240.5022018-12-14
10866614000198Subcutaneous Guidewire - Large41.240.50341.240.5032018-12-14
10866614000105CerebroFlo EVD Catheter Set37.550.50137.550.5012019-10-24
00866614000108CerebroFlo EVD Catheter Set37.550.10137.550.1012017-12-15
00866614000122Single Pass Tunneling Guidewire - Large41.157.10341.157.1032018-12-14
00866614000139Single Pass Tunneling Guidewire - Medium41.157.10241.157.1022018-12-14
00866614000146Single Pass Tunneling Guidewire - Small41.157.10141.157.1012018-12-14
00866614000153Precision Tunneler - Small41.020.50141.020.5012018-12-13
00866614000160Precision Tunneler - Medium41.020.50241.020.5022018-12-13
00866614000177Precision Tunneler - Large41.020.50341.020.5032018-12-13

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00198506093685ELMED INCORPORATEDELMED INCORPORATEDGAD2026-07-22
00841731153104ARTEMIS FUZEVILEX LLCGAD2026-07-22
00841731153111ARTEMIS FUZEVILEX LLCGAD2026-07-22
B8038600980ORTHOMEDORTHO-MED, INC.GAD2026-07-22
B8038600990ORTHOMEDORTHO-MED, INC.GAD2026-07-22
B803860120L0ORTHOMEDORTHO-MED, INC.GAD2026-07-22
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B8039601370ORTHOMEDORTHO-MED, INC.GAD2026-07-22
B8039601390ORTHOMEDORTHO-MED, INC.GAD2026-07-22
B8039601400ORTHOMEDORTHO-MED, INC.GAD2026-07-22
B803NL97010ORTHOMEDORTHO-MED, INC.GAD2026-07-22
B803NL9701H0ORTHOMEDORTHO-MED, INC.GAD2026-07-22
00190776402174MillenniumAvalign Technologies, Inc.GAD2026-07-21
00190776403317MillenniumAvalign Technologies, Inc.GAD2026-07-21
00190776403324MillenniumAvalign Technologies, Inc.GAD2026-07-21
00190776403362MillenniumAvalign Technologies, Inc.GAD2026-07-21
00840183532185BR Surgical, LLCBR Surgical, LLCGAD2026-07-21
00840183532192BR Surgical, LLCBR Surgical, LLCGAD2026-07-21
00840183532222BR Surgical, LLCBR Surgical, LLCGAD2026-07-21
00840183532239BR Surgical, LLCBR Surgical, LLCGAD2026-07-21