FDA.reportPublic FDA data

3-in-1 SHAVER™ 5.0mm

Primary DI
08592730070146
Brand
3-in-1 SHAVER™ 5.0mm
Company
RELIGN CORPORATION
Model
R-10014
Catalog number
R-10014
Device description
Multi-functional shaver blade, disposable
Published
2019-06-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HRXArthroscope

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRXArthroscopeOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K162770000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K162770000Relign SystemRelign Corporation2017-01-04GEI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
18592730070143PackageGS14In Commercial Distribution
08592730070146PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1859273007014318592730070143
08592730070146085927300701468592730070146

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bur, single-useA sterile, rotary cutting device consisting of a shaft of high-grade steel and a cutting head of hard metal/material with fluting or cutting planes of various shapes at the working end and which is designed to fit into an appropriate powered handpiece that provides the rotation allowing the user to excavate/shape bone tissue during small and large bone surgery (e.g., maxillofacial, spinal, or orthopaedic). This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter5Millimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
(866) 608-0131customer.service@religncorp.com

Regulatory Flags#

DUNS number
080031617
Device count
1
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
false
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
00889024681101STANDARD SHAVER™ 4.2MMR10029R100292025-10-07
008890246811184.2MM CURVED STANDARD SHAVER™R10030R100302025-10-07
00859273007052Dynablator™R-10005R-100052020-02-20
008592730070833-in-1 SHAVER™ 4.2mmR-10008R-100082020-07-17
00859273007120Standard Shaver 3.4mmR-10012R-100122021-03-05
008592730071443-in-1 SHAVER™ 5.0mmR-10014R-100142020-02-20
00859273007175Exoflow™R-10017R-100172020-02-20
00859273007243Curved Standard Shaver 3.4mmR-10024R-100242021-03-05
00859273007250Curved Standard Ball Burr XL 5.0 mmR-10025R-100252022-06-16
00859273007267Curved Standard Shaver XL 4.2 mmR-10026R-100262022-06-16
00859273007274Curved Dynablator® XLR-10027R-100272024-12-18
00859273007212Standard Burr 5.0mmR-10021R-100212020-10-14
00859273007236Tricera™ Handpiece, AutoclavableR-10023R-100232020-08-20
00859273007014Tricera™ ControllerR-10001R-100012020-02-20
00859273007021Tricera™ HandpieceR-10002R-100022020-02-20
00859273007038Veriflow™R-10003R-100032020-02-20
00859273007113Tricera™ Handpiece, AutoclavableR-10011R-100112020-02-20
10859273007271Curved Dynablator® XLR-10027R-100272024-12-18
10859273007257Curved Standard Ball Burr XL 5.0 mmR-10025R-100252022-06-16
10859273007264Curved Standard Shaver XL 4.2 mmR-10026R-100262022-06-16

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