N/A

GUDID 00385640022897

SUMMIT MEDICAL, INC.

Tympanostomy tube

• Primary Device ID: 00385640022897
• NIH Device Record Key: dd2f2604-fa9b-4303-9f02-570c6dae650c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: N/A
• Version Model Number: TE-7089-NS
• Company DUNS: 965484699
• Company Name: SUMMIT MEDICAL, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00385640022897 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K830228

FDA Product Code

• ETD: Tube, Tympanostomy

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[00385640022897]

Ethylene Oxide

[00385640022897]

Ethylene Oxide

[00385640022897]

Ethylene Oxide

[00385640022897]

Ethylene Oxide

[00385640022897]

Ethylene Oxide

[00385640022897]

Ethylene Oxide

[00385640022897]

Ethylene Oxide

[00385640022897]

Ethylene Oxide

[00385640022897]

Ethylene Oxide

[00385640022897]

Ethylene Oxide

[00385640022897]

Ethylene Oxide

[00385640022897]

Ethylene Oxide

[00385640022897]

Ethylene Oxide

[00385640022897]

Ethylene Oxide

[00385640022897]

Ethylene Oxide

[00385640022897]

Ethylene Oxide

[00385640022897]

Ethylene Oxide

[00385640022897]

Ethylene Oxide

[00385640022897]

Ethylene Oxide

[00385640022897]

Ethylene Oxide

[00385640022897]

Ethylene Oxide

[00385640022897]

Ethylene Oxide

[00385640022897]

Ethylene Oxide

[00385640022897]

Ethylene Oxide

[00385640022897]

Ethylene Oxide

[00385640022897]

Ethylene Oxide

[00385640022897]

Ethylene Oxide

[00385640022897]

Ethylene Oxide

[00385640022897]

Ethylene Oxide

[00385640022897]

Ethylene Oxide

[00385640022897]

Ethylene Oxide

[00385640022897]

Ethylene Oxide

[00385640022897]

Ethylene Oxide

[00385640022897]

Ethylene Oxide

[00385640022897]

Ethylene Oxide

[00385640022897]

Ethylene Oxide

[00385640022897]

Ethylene Oxide

[00385640022897]

Ethylene Oxide

[00385640022897]

Ethylene Oxide

[00385640022897]

Ethylene Oxide

[00385640022897]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-04-11

On-Brand Devices [N/A]

• 00385640040358: VC-49055
• 00385640039611: V-49052
• 00385640035071: PH-1000
• 00385640034241: SM-40240
• 00385640034234: RC-4100
• 00385640028806: SM-40075
• 00385640028288: OM-1001-SY
• 00385640027205: VT-0401-01-P
• 00385640027113: PRO-000-310
• 00385640027106: PRO-000-111
• 00385640027090: OM-4010-FX
• 00385640026314: ET-TBDT-SF-40
• 00385640026079: 0205003
• 00385640026017: ET-TBDT-45
• 00385640025683: OM-8782-R
• 00385640025676: OM-8781-R
• 00385640025669: OM-8780-R
• 00385640025294: OM-1000-KS
• 00385640024709: OM-1006-CO
• 00385640024693: OM-1005-CO
• 00385640024686: OM-1004-CO
• 00385640024679: OM-1003-CO
• 00385640024662: OM-1001-CO
• 00385640024655: OM-1000-CO
• 00385640024112: SM-45250
• 00385640024105: SM-40242
• 00385640024099: SM-40036
• 00385640024082: SM-40014
• 00385640023580: VC-49134
• 00385640023573: VC-49144
• 00385640023436: VC-49054
• 00385640023122: ET-DSDT-45
• 00385640023108: VC-49008
• 00385640023078: VC-49005
• 00385640022989: 0205006
• 00385640022903: TE-7091-NS
• 00385640022897: TE-7089-NS
• 00385640022873: TE-7091-CE
• 00385640022859: TE-7076-NS
• 00385640022842: TE-7076-CE
• 00385640022637: TE-7026-NS
• 00385640022620: TE-7026-CE
• 00385640022514: OM-4616-NM
• 00385640022507: OM-4010-IN
• 00385640022477: TE-7018-CE
• 00385640022385: TE-7014-CE
• 00385640022354: TE-7011-CE
• 00385640022293: TE-7007-CE
• 00385640020572: 0205012
• 00385640020565: 0205009