FDA.reportPublic FDA data

Tatum Surgical-Osteotome Box ( 6 space)

Primary DI
00083208000065
Brand
Tatum Surgical-Osteotome Box ( 6 space)
Company
Suncoast Dental, Inc
Model
Tatum Surgical-Osteotome Box
Catalog number
Tatum Surgical-Osteotome Box (6)
Device description
Tatum Surgical-Osteotome Box - Hold up to 6 instruments - autoclavable
Published
2020-12-07
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

Product Codes#

Code, Name table
CodeName
FSMTray, Surgical, Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FSMTray, Surgical, InstrumentGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00083208000065PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00083208000065000832080000650832080000650083208000065

GMDN Terms#

Term, Definition table
TermDefinition
Instrument tray, reusableA container intended to provide a suitable platform for placing/containing many medical/surgical instruments and related items for use during a clinical procedure; it might in addition be used during, but not dedicated to, reprocessing/sterilization procedures. It may be in the form of a shallow vessel with a raised rim, a deeper cassette-like device, or a flat or angled surface; it might include a lid. It may be designed to fit into other devices such as supply trolleys, storage systems and sterilizers, or designed to attach to a surgical/treatment table where it may be placed over the patient. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
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#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00083208003332Universal Screw Removal KitUniversal Screw Removal KitUniversal Screw Removal Kit2025-09-29
00083208163333Tatum EZ-Flex Periotome KitTatum EZ-Flex Periotome KitTatum EZ-Flex Periotome Kit2025-09-29
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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