FDA.report

Support Tube

Primary DI
00846338004101
Brand
Support Tube
Company
ELLIQUENCE, LLC
Model
16-0113
Published
2025-01-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
GEYMotor, Surgical Instrument, Ac-Powered

Product Code Classifications

CodeDeviceSpecialtyClass
GEYMotor, Surgical Instrument, Ac-PoweredGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00846338004101PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00846338004101008463380041018463380041010846338004101

GMDN Terms

TermDefinition
Spinal decompression cutting handpiece/endpieceA sterile, hand-held, powered surgical instrument designed to excise spinal (central canal and foramen) soft and hard tissue to relieve pressure (decompression) on adjacent nerve tissue, especially in the case of spinal stenosis or degenerative disk disease (DDD). It typically consists of a handpiece and integral metal (e.g., stainless steel) shaft, which may have a straight or curved tip, terminating in an exposed or shielded rotary cutting burr. The rotary action is provided by a suitable electrically or pneumatically-powered motor attached to the proximal end of the handpiece. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
019872358
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
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

Primary DIBrandModelCatalogPublished
00846338002688Motor16-01052025-01-10
00846338005566Retractor15-23212025-01-10
00846338005573Retractor15-23222025-01-10
00846338005634Bone Curette15-25322025-01-10
00846338005641Bone Curette15-25332025-01-10
00846338005658Bone Curette15-25342025-01-10
00846338005665Bone Curette15-25352025-01-10
00846338005672Bone Curette15-25362025-01-10
00846338005733Cup Forceps15-16412025-01-10
00846338005740Cup Forceps15-16422025-01-10
00846338005795Kerrison15-19242025-01-10
00846338005863Kerrison15-19342025-01-10
00846338005917Kerrison15-19392025-01-10
00846338000738ForcepsDFX-G2025-01-09
00846338001391ForcepsDFX-GS2025-01-09
00846338001513Access Needle (16 Gauge)N6-D4/12025-01-09
00846338001650Surgi-Max® Ultra - FootswitchBF-FSCB#2025-01-09
00846338001667Surgi-Max® Ultra - FootswitchTF-FSCB#2025-01-09
00846338002183Dissector11-24112025-01-09
00846338002190Probe11-24152025-01-09

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