FDA.report

Tatum Sinus Instrument

Primary DI
00083208196003
Brand
Tatum Sinus Instrument
Company
Suncoast Dental, Inc
Model
Tatum Sinus #6 - Double ended
Catalog number
Sinus #6
Device description
Tatum double ended sinus Instrument #6, (White)
Published
2020-04-10
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

Product Codes

CodeName
EMJElevator, Surgical, Dental

Product Code Classifications

CodeDeviceSpecialtyClass
EMJElevator, Surgical, DentalDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00083208196003PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00083208196003000832081960030832081960030083208196003

GMDN Terms

TermDefinition
Dental sinus lift elevatorA hand-held, manual, dental surgical instrument specially designed to lift and displace sinus mucosa (Schneiderian membrane) from the maxillary sinus floor to allow for insertion of a bone graft during sinus lift surgery. It is typically a metal instrument with single- or double-ended blades. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
727-536-4880tatumcompliance@gmail.com

Regulatory Flags

DUNS number
078352849
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

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00083208191121Tatum Sinus Instrument Kit Tatum Sinus KitTatum Sinus Kit2024-09-25
00083208162220Tatum EZ Out Periotome E KitTatum EZ Out Periotome E KitTatum EZ Out Periotome E Kit2024-07-30
00083208135002DDP Dental MirrorDental MirrorDental Mirror2024-01-30
00083208136702DDP Extraction ForcepsForceps (67-A)Forceps (67-A)2024-01-30
00083208452215Tatum Surgical IP Press Fit AbutmentIP-PN-4.5 x 2 (CB) AbutmentIP-PN-4.5 x 2 (CB)2021-06-04
00083208453212Tatum Surgical IP Press Fit AbutmentIP-PN-4.5 x 3 (CB) AbutmentIP-PN-4.5 x 3 (CB)2021-06-04
00083208454219Tatum Surgical IP Press Fit AbutmentIP-PN-4.5 x 4 (CB) AbutmentIP-PN-4.5 x 4 (CB)2021-06-04
00083208455216Tatum Surgical IP Press Fit AbutmentIP-PN-4.5 x 5 (CB) AbutmentIP-PN-4.5 x 5 (CB)2021-06-04
00083208456213Tatum Surgical IP Press Fit AbutmentIP-PN-4.5 x 6 (CB) AbutmentIP-PN-4.5 x 6 (CB)2021-06-04
00083208502217Tatum Surgical IP Press Fit AbutmentIP-PN-5.0 x 2 (CB) AbutmentIP-PN-5.0 x 2 (CB)2021-06-04
00083208503214Tatum Surgical IP Press Fit AbutmentIP-PN-5.0 x 3 (CB) AbutmentIP-PN-5.0 x 3 (CB)2021-06-04
00083208504211Tatum Surgical IP Press Fit AbutmentIP-PN-5.0 x 4 (CB) AbutmentIP-PN-5.0 x 4 (CB)2021-06-04
00083208505218Tatum Surgical IP Press Fit AbutmentIP-PN-5.0 x 5 (CB) AbutmentIP-PN-5.0 x 5 (CB)2021-06-04
00083208506215Tatum Surgical IP Press Fit AbutmentIP-PN-5.0 x 6 (CB) AbutmentIP-PN-5.0 x 6 (CB)2021-06-04
00083208130526DDP Depth GaugeDepth GaugeDepth Gauge2022-10-19
00083208130427Zoll Scalpel Handle RoundScalpel Handle Round Z-4206 XLScalpel Handle Round2022-08-08
00083208131004DDP Extraction Forceps Forceps (1-A)Forceps (1-A)2022-06-30
00083208131509DDP Extraction Forceps Forceps (150-A)Forceps (150-A)2022-06-30

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