FDA.report

ReLine

Primary DI
00887517764751
Brand
ReLine
Company
Nuvasive, Inc.
Model
10001285
Device description
RSS Counter Torque, Offset Conn
Published
2018-09-24
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

Product Codes

CodeName
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Product Code Classifications

CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00887517764751PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00887517764751008875177647518875177647510887517764751

GMDN Terms

TermDefinition
Orthopaedic counter-torque/rod-pushing instrumentA hand-held, manual, tube-like surgical instrument with a right-angled handle designed to apply a rotational force that opposes the directional force of torque when tightening (locking) a screw or screw head setscrew with a screwdriver, inserted down the instrument's hollow centre, during orthopaedic surgery. In addition, it may be used to push (seat) an orthopaedic rod into the slotted screw heads of screws that have been inserted into bone (e.g., vertebrae). It is typically made of high-grade stainless steel or titanium alloy, and synthetic materials. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(858)909-1800RA_UDI@nuvasive.com
+1800-475-9131nuvainfo@globusmedical.com

Regulatory Flags

DUNS number
053950783
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

Primary DIBrandModelCatalogPublished
00887517377692CoRoent68510122015-10-24
00887517390516CoRoent69102452015-10-24
00195377172204ReLineD24001502026-03-04
00195377173102RELINE24002002025-12-09
00195377173904RELINE110108902025-12-09
00195377173911RELINE110108952025-12-09
00195377147585ReLine24000052025-08-01
00195377147592ReLine24000062025-08-01
00195377148209ReLine24000072025-08-01
00195377148216ReLine24000102025-08-01
00195377148223ReLine24000502025-08-01
00195377148261ReLine243500202025-08-01
00195377148278ReLine243500252025-08-01
00195377148285ReLine243500302025-08-01
00195377148292ReLine243500352025-08-01
00195377148308ReLine243500402025-08-01
00195377148315ReLine243500452025-08-01
00195377148322ReLine243500502025-08-01
00195377148339ReLine243500552025-08-01
00195377148346ReLine243500602025-08-01

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